Method of treating urinary incontinence by implanting a transvaginal mid-urethral sling into a person

ABSTRACT

A method of treating urinary incontinence by implanting a transvaginal mid-urethral sling into a person includes engaging an introducer needle with an extension of an implant; advancing the introducer needle and the extension of the implant from a vaginal incision, along a first path posterior to a pubic bone, and through an abdomen of the patient; and disengaging the introducer needle from the extension of the implant and withdrawing the introducer needle backward along the first path from posterior to the pubic bone out of the vaginal incision.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/719,323, filed on May 22, 2015, which is a continuation of U.S.patent application Ser. No. 14/274,432, filed May 9, 2014, now U.S. Pat.No. 9,532,862, which is a continuation of U.S. patent application Ser.No. 13/350,655, filed Jan. 13, 2012, now U.S. Pat. No. 9,005,222, whichis a continuation of U.S. patent application Ser. No. 10/633,254, filedAug. 1, 2003, now U.S. Pat. No. 8,097,007, which claims the benefit ofU.S. Provisional Patent Application No. 60/400,616, filed Aug. 2, 2002,and U.S. Provisional Patent Application No. 60/479,039, filed Jun. 17,2003, each of which is incorporated herein by reference in its entiretyand for all purposes.

BACKGROUND OF THE INVENTION

Various surgical techniques benefit from the use of non-native flatsupporting members inserted into the patient's body to apply pressure tothe patient's own tissue. Such implanted supporting members can be madefrom synthetic material, natural material, whether harvested from thepatient or elsewhere, or composites of both synthetic and naturalmaterials. When using harvested natural material, it may be desirable totreat the source tissue to alter its physical properties to insure it isbiocompatible and does not cause an adverse reaction with the patient'simmune system.

One example of a sheet-like support structure for use in a range ofsurgical techniques IS described in U.S. Pat. No. 6,197,036. This patentdiscloses a pelvic floor reconstruction surgical patch made from naturalor synthetic biocompatible material. According to the ‘036 patent, thepreferred material for use in the patch is synthetic fabric made frompolyester, more preferably, collagen coated polyester. The patch has anumber of holes which are arranged in a specific manner with respect tothe patch's corners.

Another material that can be used as a patch to reinforce soft tissue isprocessed porcine intestinal tissue. Examples of support structures madefrom such material include the Surgisis® Gold™ Hernia Repair Grafts, theSurgisis® Soft Tissue Grafts, and the Surgisis® IHM™ Inguinal HerniaMatrix, all manufactured by Cook Surgical, of Bloomington, Ind. anddescribed in Cook Surgical's literature.

An increasingly widespread technique for treating female urinaryincontinence is that of sling suspension. Examples of such proceduresand equipment which can be employed are discussed in U.S. Pat. Nos.5,112,344, 5,899,909, and 6,273,852 BI. In this technique, a flatsupporting member is used to treat female urinary incontinence bypermanently positioning a strip-like sling beneath the patient'surethra. By implanting the sling and then adjusting the sling to apply adesired level of force to the patient's urethra, the amount of pressurewhich the patient must thereafter exert to void her bladder isincreased, improving continence. The sling member is preferablyimplanted in the patient's tissue by using a needle to draw the slinginto its approximate position. Then, the surgeon can make fineadjustments to properly locate the sling member, and to apply therequired amount of tension to the tissue requiring support.

Although originally implanted slings were anchored in the patient'sbody, for example, by using sutures to join the sling ends to thepatient's pelvis, it is now more common to leave the sling endsunattached. The sling is maintained in position through friction betweensling material and the patient's own tissue, in particular, in the caseof a sling implanted in the lower abdomen, with the rectus fascia. Thisapproach is known as a “self-anchoring” or “tension-free” procedure.

In self-anchoring sling support procedures it is important that thesling be held firmly in place by friction with the patient's tissue.Should the ends of the sling slip, then insufficient support will beprovided for the urethra to alleviate incontinence, and the procedurewill be unsuccessful. It is also important that the sling material usedbe strong enough to withstand, without rupture or tear, any forces thatare encountered following implantation, for example, when the patientsneezes.

Slings can be made from tape or mesh. Numerous implant materials havebeen considered and used for sling procedures, including both syntheticmesh and natural tissue.

Although easy to sterilize, strong and inexpensive, synthetic meshmaterial has a number of shortcomings which will be discussed in furtherdetail below. Just by way of example, when synthetic mesh material isused as a sling support, the roughness of the synthetic mesh may lead toabrasion of the patient's urethra, and that can cause infection and/orerosion of the patient's tissue.

When performing sling support procedures, it is important to use animplant which is well-tolerated by the patient's immune system. To thisend, sling supports can be made from processed natural material. Oneexample of such a processed tissue sling support is the Stratasis® TFsupport, manufactured by Cook Urological, Inc. of Spencer, Ind. TheStratasis® TF support is a three-dimensional extracellular matrix whichincludes collagen, non-collagenous proteins, and biomolecules that ismade of natural biomaterial derived from the small intestine of pigs.The Stratasis® TF support is gradually replaced by the patient's body.

A traditional sling procedure involves placing a narrow strip of animplant material (natural tissue or synthetic mesh) under the urethraand securing it to the rectus fascia or other portions of the patient'sanatomy with sutures to hold the implant in position during the healingprocess.

More recently, a newer technique has been used to place a strip ofsynthetic mesh under the urethra without securing the mesh in place withsutures. In this technique, the implant member is held in place duringthe healing process by the friction between the mesh and the surroundingtissue. This improvement, which employs specialized instrumentation, hashelped reduce operative time and has made the procedure less invasive.

Although each of these techniques has demonstrated good results, eachhas a number of potential complications, due, in part, to the type ofmaterial from which the sling is formed.

Synthetic mesh is used with the self-anchoring techniques. Among thebenefits to using synthetic mesh material is that the friction of thesynthetic mesh with the surrounding tissue allows for suture-freeplacement of the mesh strip. “Kits” are commercially available whichinclude a suitable mesh implant member and the small needles needed topass the synthetic mesh implant member into the patient's body; fewother surgical instruments are required. This has resulted in a simplerand less invasive procedure in which only small incisions are required,no patient tissue need be harvested, and just a short hospital stay isrequired.

Clinical articles have suggested that the synthetic mesh material usedin this procedure is subject to a higher risk of causing erosion of thepatient's tissue than are natural materials. Furthermore, the syntheticmesh material has a higher risk of infection than does natural material,probably because the mesh provokes a foreign body reaction from thepatient's body or may harbor bacteria around the mesh. The syntheticmesh material also tends to have a greater amount of scar tissueformation around the mesh fibers, instead of vascular ingrowth.

Natural materials, for example, autologous, allograft, or xenografttissues, or soft collagen fiber engineered materials, which are used intraditional techniques, offer such benefits as a lower risk of erosionthan the synthetic materials. Natural materials also have a lower riskof infection, presumably because there is no foreign body reaction. Thenatural materials also experience better tissue ingrowth than thesynthetic materials because they are made up of collagen fibers, whichcan serve as a tissue-building framework.

Disadvantageously, the natural materials require sutures be used toanchor the material in position. To implant the natural material slings,traditional instrumentation is used. Such instrumentation often requiresmore invasive surgical techniques, larger incisions, harvesting of thepatient's own tissue for use as the sling, and consequently, may resultin a longer hospital stay.

Although natural support members offer many benefits when used in themanner described above (for example, they are not abrasive), they alsoare generally more expensive than their synthetic counterparts, sincesuch support members are derived from natural source materials that mustbe treated to insure sterility, stability and biocompatibility.

Given the expense of natural support members, it is desirable to reducethe amount of natural material used in each support member without alsoreducing the self-anchoring properties, positioning ability, strength ordurability of that support member.

There also exists a long-felt and unsolved need for a support system,and, in particular, a sling suspension system which offers therespective cost and tolerance benefits of both synthetic and naturalmaterials, without the weaknesses of either of those techniques.

Although some doctors are satisfied with the results that they haveachieved using synthetic mesh sling kits, other doctors prefer not touse the synthetic materials due to the materials’ higher potential forcomplications such as the occurrence of infection or foreign bodyreaction around the mesh, or urethral or vaginal wall erosion due to themesh. In some cases of erosion, mesh has been observed to unravel,creating a sharp “fishing line” effect, which can slice through thepatient's tissue. This is not a concern with natural fibrous materialssuch as autologous, allograft, or xenograft tissues, which elongate lessand do not neck down under load.

Existing surgical hardware, such as the McGuire™ suture guide, which hasa central suturing hole, and available from C. R. Bard, Inc. of MurrayHill, N.J., is based upon what is known as the “Stamey” needle. Althoughsuch devices could be modified for use in the field of this invention,they do not possess all the requisite properties for the uses envisionedfor this invention.

Thus, there exists a long-felt and unsolved need for a sling suspensionsystem which offers the distinct benefits of both synthetic and naturalmaterials, without the weaknesses of either of those techniques.

SUMMARY OF THE INVENTION

First, it should be understood that although this disclosure speaks ofthe sling suspension of the female urethra, this invention is not to belimited thereto. By way of non-limiting example, the devices andtechniques taught herein could be employed to support other body organssuch as the bowel or bladder. Consequently, all portions of thisdescription should be understood to encompass such alternative uses ofthis invention, as well as all modifications in size and proportion ofthe disclosed invention's parts which may be required to implement thosealternative uses.

Taken together, the components used in this invention and describedhereafter provide a minimally invasive, simple technique that is easilylearned and which requires little operative time. The implant memberwill offer the low complication rate and good tissue ingrowth of anatural material, while the texturing provides the self-anchoringproperties of a synthetic mesh, thereby eliminating the need for suturesor other anchoring means.

Among the benefits of this invention is improved flexibility; thesurgeon can use this system for either an upward or a downward approachwithout any need to employ special equipment.

The present invention is intended to provide a self-anchoring sling kit,using natural material, hybrid material, or even synthetic material,which is an improvement upon known systems. This system takes advantageof the best features of both synthetic mesh and natural tissue implants,using those materials separately or together, and provides an excellentcombination of versatility, ease of use, and safety.

The invention also concerns a new device and technique to treat stressurinary incontinence in women. The technique is a modification of atraditional pubourethral sling procedure, which is done to provide anunderlying support to the urethra.

More specifically, the present invention is directed to a system forsupporting the urethra which includes an introducer needle at least oneor both of the ends of which are flattened and which have openingstherethrough, a handle having a latch mechanism which engages theopening in the flattened portion of the first end of the introducerneedle, an implant member, and a connector joining the end of theimplant member to the flattened portion of one of the ends of theintroducer needle.

One aspect of this invention involves a system for supporting a femaleurethra having an introducer needle with first and second ends, each endhaving a flattened portion with an opening therethrough, a handle havinga latch mechanism which engages the opening in the flattened portion ofthe first end of the introducer needle, an implant member having an endand a connector joining the end of the implant member to the flattenedportion of the second end of the introducer needle. The introducerneedle can be curved and symmetrical, and the flattened portion of thefirst end may differ in size from the flattened end of the secondportion. The introducer needle can have a flared section with across-sectional profile that is larger than a cross-sectional profile ofthe connector.

This invention also is drawn to a connector for attachment to the end ofan implant member having an arm having a hole therethrough or anintroducer needle including a flat spatulated section having an opening.The connector has a central portion, a first arm pivotally mounted tothat central portion and having a first opening at a first end, a secondarm pivotally mounted to the central portion and having a firstprojection extending therefrom, the first projection being positioned sothat when the first arm and the second arm move together, the firstprojection is received in the first opening, and an implant attachmentstructure to which the implant member is connected. Teeth or a“+”-shaped boss may protrude from the arm surfaces to engage the implantmember. Any other suitable boss shape, such as a hemisphere or cylinder,also could be used. A second set of arms also may be provided.

Still another aspect of this invention is a connector for attachment toan implant member or an introducer needle including a flat spatulatedsection having an opening. This includes an elongated base portionhaving a first engaging structure at a first end and a second engagingstructure at a second end, a first arm pivotally mounted to theelongated base portion and having a third engaging structure, the thirdengaging structure being positioned so that when the first arm pivotstoward the elongated base portion, the first and the second engagingstructures meet and engage, and a second arm pivotally mounted to theelongated base portion and having a fourth engaging structure, thefourth engaging structure being positioned so that when the second armpivots toward the elongated base portion, the second and fourth engagingstructures meet and engage. The engaging structures can be matingopenings and projections.

Additionally, this invention relates to a connector for attachment to animplant member or an introducer needle with a flat spatulated sectionhaving an opening. The connector has an elongated base portion with afirst engaging structure, an arm pivotally mounted to the elongated baseportion and having a having a second engaging structure, the engagingstructures meeting when the arm pivots toward the elongated baseportion, and an attachment point for connection to an implant member.The engaging structures may have openings and projections that can meet.The attachment point can be joined to the implant member by a staple, arivet, an adhesive or a suture, for example.

A further aspect of this invention is an introducer needle for use in asurgical procedure having a central portion, first and second flatspatulated sections that may be integral with the central portion, atleast one flat spatulated section having a tip and a constant widthportion disposed between the tip and the central portion, and an openingformed in the flat spatulated section, and a flared section connects thefirst flat spatulated section to the central portion. The flared sectionhas a cross-sectional profile that covers a cross-sectional profile ofthe first flat spatulated section. The introducer needle may beasymmetric. The spatulated sections may have different shapes.

Another introducer needle has a first flat spatulated section, a firststraight portion connected to a distal end of the first flat spatulatedsection, a curved portion connected to a distal end of the firststraight portion, a second straight portion connected to a distal end ofthe curved portion, a second flat spatulated section connected to adistal end of the second straight section, and a flared sectionconnecting the first flat spatulated section to the first straightcentral portion, the flared section having a cross-sectional profilethat covers a cross-sectional profile of the first flat spatulatedsection. At least one flat spatulated section has a tip and a constantwidth portion disposed between the tip and the central portion, and anopening formed in that the flat spatulated section. The spatulatedsections, flared section, straight portions and curved portions can beintegrally formed. The straight portions may differ in length.

Also, an introducer needle can have a body portion with a proximalstraight portion integral with a distal curved portion, a handlereceiving the proximal end of the straight portion and a flat spatulatedsection having a “T”-shaped opening located at the distal end of thecurved portion. The handle may be permanently attached to the straightportion.

An introducer needle for use in a surgical procedure employing afilament has a tubular body, a rod disposed in the tube's lumen, and aneedle tip movably disposed in the lumen at the distal end of thetubular body and attached to the rod, the needle tip having an openingtherein for receiving the filament. When the rod is moved toward thedistal end of the tubular body the needle tip moves forward.

Another introducer needle has a body portion with a curved portion, aflared section located at the distal end of the curved portion, and aflat spatulated section having a “T”-shaped opening located at thedistal end of the flared section, a leg of the “T” extending to an edgeof the flat spatulated section.

An introducer needle for use in a surgical procedure includes a bodyportion with a curved portion, a flared section located at the distalend of the curved portion, and a flat spatulated section having aninternal opening located at the distal end of the flared section.

The internal opening may be “H”-shaped or substantially rectangular, andin the latter case, can have a central portion larger in size than afront end and a back end of the internal opening.

Also, a handle for an introducer needle having a flat spatulated sectionhaving an opening includes a housing with an elongated portion having adistal end with an opening therethrough, the opening being dimensionedto receive the flat spatulated section and hold the flat spatulatedposition in a connecting position in the housing, and anelastically-biased latch portion having a projection dimensioned anddisposed so that when the flat spatulated section is received by theopening and is held in the connecting position, the projection passescooperates with the opening to secure the handle to the introducerneedle. The housing may be made from two shells, and also can include aninsert with a slot dimensioned to receive the flat spatulated section,the insert being disposed between the shells. A weight may be disposedwithin the housing.

According to this invention, an implant member includes a centralportion with first and second sides, first and second arm sectionsintegral with the first and second sides of the central portion,respectively, at least one of the first and second arm sections havingan irregular border. At least one of the central portion and the firstand second arms can have an edge with slits or openings therein.

A different implant member includes an elongated body of flexiblematerial with first and second ends and a central portion that includesan axis running along a length of the implant member. The centralportion has slits arranged along the axis, the slits moving out of theimplant members plane when tension is applied to the implant member.

Still another implant member has a central portion with first and secondends, and first and second arms joined to the first and second ends,respectively. The central portion can be made of a material that isdiffered from the first and second arms, possibly natural and syntheticmaterials, respectively.

Still another implant member includes an elongated body with slits thatopen when tensile force is applied to the body.

Also, the implant member can include a body with first, second and thirdsections, the second section being located between the first and thethird sections, the first and the third sections each having slitstherein that open when tensile force is applied to the body. These slitscan be arranged in rows, and the rows can be parallel. Slits inadjoining rows can be staggered in position.

A different implant member has first and second extension loops and asupport section with first and second ends having holes, the firstextension loop passing through one hole and the second extension looppassing through another hole. Connectors with structure for attachmentto a needle tip can be joined to the extension loops.

An implant can be made by providing a body and forming slits in the bodythat are arranged to open when tensile force is applied to the body.These slits can be arranged in rows, which may be parallel. A skin graftmesher can be used to create the slits in the body.

Methods of providing support for a female urethra are taught thatinvolve creating at least one incision in the patient's abdominal wallat the level of the pubic symphysis, creating an incision in theanterior vaginal wall just below the urethral meatus, advancing anintroducer needle, having a detachable handle joined thereto, into theretropubic space via the incision in the patient's abdomen and downwarduntil the needle is exposed at the vaginal incision, connecting one endof an implant member to the end of the introducer needle protruding fromthe vaginal incision using a permanent snap-on tissue connector,withdrawing the introducer needle through the abdominal incision withthe implant member attached, and positioning the implant member looselyunder the urethra by at least one of gently pulling on the abdominal endof the implant member and by loosening the implant member by pulling onthe implant member with a clamp at the vaginal incision.

Also, a method of providing support for a female urethra can involvescreating at least one incision in the patient's abdominal wall at thelevel of the pubic symphysis, creating a second incision in the anteriorvaginal wall below the urethral meatus, advancing an introducer needle,having a detachable handle joined thereto, through the vaginal incisionupward until the introducer needle tip is exposed through the firstabdominal incision, connecting one end of an implant member to the endof the introducer needle protruding from the vagina using a permanentsnap-on tissue connector, drawing a portion of the implant inwardthrough the vaginal incision and through the first abdominal incision,and positioning the implant member loosely under the urethra by at leastone of gently pulling on the abdominal end of the implant member and byloosening the implant member by pulling on the implant member with aclamp at the vaginal incision.

Among the benefits of this invention is improved flexibility; thesurgeon can use this system for either an upward or downward approachwithout the need to employ special equipment.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawing figures, which are merely illustrative, andwherein like reference characters denote similar elements throughout theseveral views:

FIGS. 1A is a perspective view of an introducer handle with pushbuttonaccording to the present invention, seen from the front, right side andtop, and FIG. 1B is a perspective view of the bottom shell portion ofthe handle shown in FIG. 1A;

FIG. 2 is a perspective view of a dual-ended introducer needle accordingto the present invention, seen from the front, right side and top;

FIG. 3A is a perspective view showing the handle connected to anintroducer, as seen from the front, right side and top, and FIG. 3B is aperspective exploded view of the assembled components shown in FIG. 3A;

FIGS. 4A-B show the introducer handle with the top portion removed, FIG.4B showing the components in exploded form;

FIG. 5A is an exploded view showing another embodiment of a handle andneedle in accordance with this invention; FIG. 5B shows the assembledhandle as the needle is being inserted thereinto, FIG. 5C depicts theneedle as received in the handle, and FIG. 5D illustrates the needlereceived in the handle and covered by a sheath;

FIGS. 6A and 6B are close-up perspective views showing, respectively,the blunt and pointed tips of the needle depicted in FIG. 5A;

FIG. 7A is a side elevational view of a permanent snap connectoraccording to a first embodiment in the open position, FIGS. 7B and 7Care perspective views in the open and closed positions, and FIG. 7D is aside elevational view in the closed position of the connector shown inFIG. 7A;

FIGS. 8A is a perspective views of a second embodiment of a permanentsnap connector design, FIG. 8B being a side elevational view of theconnector shown in FIG. 8A;

FIGS. 9A-C are, respectively, top plan, side elevational and frontelevational views of a further connector in accordance with thisinvention, the connector being in a closed configuration; FIG. 9D is aside elevational view showing the same connector in an openconfiguration;

FIG. 10 is a perspective view of a modified version of the connectorshown in FIGS. 7A-D;

FIGS. 11A-B are side elevational views showing how the connector of FIG.10, in closed configuration, resists the application of closing force;

FIG. 12 is a perspective view of a textured natural tissue implant;

FIG. 13 is a perspective view showing the assembled introducer needle,connector and tissue implant;

FIGS. 14A and 14B are perspective views showing the connector of FIGS.9A-D being affixed to an introducer needle;

FIGS. 15A-C are front, side and perspective views showing the connectorof FIGS. 9A-D affixed to an implant member and a introducer needle;

FIGS. 16A-D are perspective views showing the assembly of an introducersystem and implant member in accordance with the present invention usingthe connector depicted in FIGS. 7A-D;

FIGS. 17A-D are views depicting various implant members in accordancewith the present invention;

FIG. 18A depicts an implant member in accordance with the presentinvention in a tension-free state, and FIG. 18B shows that implantmember when tension is applied thereto;

FIGS. 19A-E are views showing the configuration of different internalslits in various implant members according to this invention;

FIGS. 20A-E are views showing the configurations of different implantmembers in accordance with this invention;

FIG. 21A is a front view and FIG. 21B is a side view showing how animplant member in accordance with this invention deforms as it passesthrough a layer of tissue;

FIGS. 22A-F are views showing various implant member configurations;

FIGS. 23A and 23B are perspective views showing changes in shape of animplant member as it passes through a layer of tissue;

FIGS. 24A-C are views showing alternative implant member arrangements inaccordance with this invention;

FIGS. 25A-C are views showing how an implant member with straight butslitted edges can be secured in tissue;

FIGS. 26A-E are top plan views showing a number of different implantmember configurations having internal slits to improve anchoringproperties over a flat member;

FIG. 27 is a top plan view of a composite implant member;

FIGS. 28A-28G are views showing various ways to assemble a compositeimplant member in accordance with this invention;

FIG. 29 is a close-up perspective view of a portion of a slitted supportmember prepared in accordance with this invention and which is in therelaxed (unexpanded) state;

FIG. 30 is a close-up perspective view of portion of the slitted supportmember of FIG. 29 under tension, in the expanded state;

FIG. 31 is a perspective view of a support member suitable for use in aurethral sling suspension procedure;

FIGS. 32A and 32B depict a support in accordance with this invention inthe unexpanded and expanded state, respectively;

FIG. 33 is a top plan view depicting the support member of FIG. 31 in anexpanded state as a result of tension applied thereto;

FIG. 34 is a top plan view in close-up showing a further embodiment ofthis invention having an alternate arrangement of slits;

FIG. 35 is a top plan view showing an embodiment of this invention inwhich all but the ends of the implant have slits;

FIG. 36 is a top plan view of still another embodiment of this inventionhaving an enlarged central section to better support body tissue;

FIG. 37 is a close-up of a portion of FIG. 36;

FIG. 38 is a perspective view showing one embodiment of an implantmember used with connectors, and in the non-expanded state;

FIG. 39 is a perspective view showing another embodiment of an implantmember used with connectors;

FIGS. 40 and 41 are perspective views showing two different types ofconnectors;

FIG. 42 is a perspective view showing another form of implant member;

FIGS. 43A-C are front perspective views showing several alternateconfigurations of the implant member of FIG. 42;

FIGS. 44A and 44B are front perspective views of the implant member ofFIG. 42 showing the effect of force applied thereto;

FIG. 45 is a perspective view of an implant member;

FIGS. 46A and 46B are perspective views showing a portion of the implantmember of FIG. 45 during placement in a patient;

FIG. 47 is a side cross-sectional view showing the implant member ofFIG. 45 as positioned in a patient's body;

FIG. 48 is a perspective view of another implant member;

FIG. 49 is a side cross-sectional view showing the implant member ofFIG. 48 during positioning in a patient;

FIG. 50A is a perspective view of a connector suitable for use with theimplant member shown in FIG. 45; FIG. 50B is a perspective view of analternate version of the connector of FIG. 50A, and FIG. 50C depictsanother version of a connector joined to the implant member of FIG. 45;

FIGS. 51A and 51B are perspective and side cross-sectional views showinganother embodiment of this invention;

FIG. 52 is a side cross-sectional view showing another embodiment ofthis invention;

FIGS. 53A and 53B are side views showing how an implant member such asthat shown in FIG. 45 is attached to an introducer needle;

FIG. 54 is a side cross-sectional view showing the embodiment of FIG. 45during implantation in a patient's body;

FIG. 55 is a simplified cross-sectional view of an introducer needleaccording to this invention;

FIGS. 56A-C are side plan views showing a portion of the introducer ofFIG. 55 in different stages of use;

FIGS. 57A-C are perspective views showing different steps in the use ofan implant member in accordance with this invention;

FIGS. 58A-G are side elevational views showing different ways of formingloops for use with an implant member in accordance with this invention;

FIG. 59 is a perspective view showing a portion of a loop connectoraccording to this invention;

FIGS. 60A and 60B are perspective views showing another embodiment ofthis invention in which a loop is captured by an introducer needle;

FIGS. 61A and 61B are perspective views showing another embodiment ofthis invention in which a loop connector is captured by an introducerneedle;

FIGS. 62A and 62B are perspective views showing another embodiment ofthis invention in which a loop connector has a projection that iscaptured by an introducer needle; and

FIGS. 63A and 63B are perspective views showing another embodiment ofthis invention in which a loop connector has a projection that iscaptured by an introducer needle.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, the various embodiments of the presentinvention will be discussed in detail.

In the following discussion, like numbers will be used to describe likeportions of the different embodiments.

With general reference to FIG. 13 for the purpose of introducing vanouscomponents of the present invention, this invention involves an implantmember 1, which can be made of natural material, synthetic material, ora combination thereof, and which can be textured or slit, and also anintroducer system having a handle 5, a connector 7, and an introducerneedle 3. The purpose of this invention is to place a piece of materialbeneath the patient's urethra so that the urethra is supported, helpingto prevent the involuntary release of urine from the bladder. Using thisinvention implants also could be placed in other parts of a patient'sbody to support other body organs.

Together, these components facilitate a minimally invasive and simpletechnique that is easily learned and which requires little operativetime. The implant member 1 is designed to have both a low complicationrate and good tissue ingrowth of a natural material, while the texturingof the implant member 1 provides the self-anchoring properties of asynthetic mesh, eliminating the need for sutures or other anchoringmeans.

As will later be discussed in detail, the handle 5 allows the surgeon toguide accurately the introducer needle 3 into the patient's body, andincreases device safety greatly when compared to a conventionalimplantation system wherein the surgeon directly grasps a needle withouta handle (not shown). One end 4 of the introducer needle 3 is receivedin and is securely held by the handle 5. The other, free, end 4 of theintroducer needle 3 is joined to the implant member 1 by a connector 7.Using the handle 5 the surgeon can draw the implant member 1 into placebeneath the patient's urethra. The implant member 1 is then detachedfrom the introducer needle 3 and is positioned as the surgeon wishes.

As will now be discussed in detail, this invention involves severaldifferent handle configurations, each of which can receive introducerneedles that are suitable for performing a sling suspension procedure.Several different needle configurations are also proposed. In addition,a variety of different connectors for joining implant members to theneedles are taught, and a number of implant members are disclosed. Someimplant members can be joined directly to the needle.

As depicted in FIGS. 3A and 3B, the introducer system of the presentinvention includes a curved, double-ended introducer needle body 3having blunt-tipped stainless steel introducer tips 4 at each end, and amodular handle 5 that can be attached to one of the ends 4 of theintroducer needle 3. This introducer system is used with a tissueconnector 7, as shown in FIG. 13. The tissue connector 7 allows theimplant member 1 to be quickly and securely joined to the introducerneedle 3. The handle 5 provides a solid, ergonomic interface, enablingthe user to advance the introducer needle 3 into the patient's body witha high degree of control.

The handle 5 can be securely locked onto the introducer needle 3, yetstill can be easily detached by depressing a pushbutton 9. As explainedbelow, the pushbutton 9 releases the internal handle structure whichholds the introducer needle 3 in place on the handle 5.

As will also be discussed later, at least one and possibly both ends 4of the introducer needle has a flat, spatulated section 13 with arounded tip 15 that serves as a dissecting tip enabling the clean andatraumatic dissection of the patient's tissue during insertion. Theflat, spatulated section 13 also helps the introducer needle 3 remainclose to the surface of the pubic bone during the insertion procedure.The rounded tip 15 serves to minimize unintended perforations of thebladder and other organs or vessels. The introducer needle 3 isdimensioned and curved to reflect the curvature of the posterior surfaceof the pubic bone, allowing the introducer needle 3 to stay in the “zoneof safety” during placement. Symmetric or asymmetric introducers needles3 can be used.

The present invention contemplates a handle 5 that can be removablyjoined to the introducer needle 3, as depicted in FIGS. 1A, 16, 3A, 3B,4A, 4B, and 5A-5C. Each of these drawings show somewhat differentembodiments of the handle 5, but all are intended to improve safety byallowing the surgeon to securely hold and manipulate the introducerneedle 3 received therein.

With reference now to FIGS. 1A and 113, a first embodiment of handle 5is preferably assembled from upper and lower shell portions 6 a, 6 bwhich, when joined together, have the desired handle shape, and whichare designed to accommodate various handle components, discussed below.The handle 5 allows a solid, ergonomic interface for the user to advancethe introducer needle 3 into the patient.

With continued reference to FIGS. 1A and 16, handle 5 is preferablygenerally “T” shaped, with the long leg 29 of the “T” being internallyshaped to receive one of the two spatulated sections 13 of theintroducer needle 3 (the handle 5 also can be designed so that only oneend of an asymmetric introducer needle can be received therein). Thelong leg 29 of the “T” shape can facilitate orientation and use of thepresent invention, and can be used for guidance, as well as to indicatethe position of the introducer needle 3. A further benefit of thisarrangement is that the long leg and horizontal bar of the “T”facilitate orientation of the needle held by the handle.

Turning now to FIGS. 5A-C, an asymmetric introducer needle 3 is shown.The asymmetric geometry of this introducer needle 3 provides thebenefits of having a tight bend radius as the distal end for closepassage around the pubic bone, and a straight portion at the proximalend increases the working length of the needle. This working length isimportant because it allows the introducer needle 3 to fully extendbetween the suprapubic and retropubic incisions during use.

In contrast, if a dual-ended symmetric needle 3′ such as that shown inFIG. 2 is used, it may be necessary to make compromises in needle designin order to obtain both a tight symmetrical curvature and, at the sametime, an adequate working length.

In a further aspect of this invention, and with reference now to FIGS.5A-C and 6A-B, the flat portions 13 of the introducer needle 3 are madewith different sizes and shapes in order to help insure that theintroducer needle 3 is properly oriented during use.

As seen in FIG. 6A, the flat portion 13 of the needle tip which adjoinsthe flared portion 47 of the needle and fits into the handle 5 where itis secured by the latch mechanism 33 preferably is made generallyrectangular in shape. This flat portion 13 has a width W.

In contrast, as shown in FIG. 6B, the flat portion 13 of the needle tip4 which passes through the patient's tissue has a pointed dissecting tip16 a having a gradual taper that facilitates advancement of the flatportion 13 through such tissue. This needle tip 4 also can be somewhatwider in width W than the needle tip 4 which is received in the handle5, since, as noted above, this prevents the needle 3 from beinginstalled backward in the handle 5.

In addition, each of the flat portions 13 shown in FIGS. 6A and 6B has acentral slot or opening 27, which, as already explained, insures thatwhen the introducer needle 3 is joined to a connector 7 those parts areattached with the proper orientation.

As can be seen in FIGS. 1A-B and 4A-B, the end of the long leg 29 of the“T” formed by the joined upper and lower shells 6 a, 6 b has a smallhole or slot 25 therein and an internal cavity 31 sized to securelyreceive most of the spatulated end 13 of a symmetric introducer needle3′ or, if an asymmetric needle 3 is used, the blunt end 16 b of theintroducer needle 3 intended to be secured in the handle 5. The handle 5can be securely locked onto an introducer needle 3, yet also can beeasily detached by depressing a pushbutton 9, as will be discussedbelow.

The edges of the two shell portions 6 a, 6 b are preferably arranged toform a lap joint (not shown) when assembled. Optionally, the shellportions 6 a, 6 b can be arranged with one shell 6 a having projectingpins (not shown) and the other shell 6 b having matching receptacles 10,preferably located at stress points. It is thought to be preferable toemploy round pins and hexagonal holes 10; this way, air or adhesivepockets are avoided when the upper and lower shells 6 a, 6 b are joined,the air or glue escaping through the gaps formed between the differentshaped parts, but any other hole and pin configuration, such as round orsquare, matching or nonmatching, also could be employed.

Also by way of non-limiting example, the upper and lower shell portions6 a, 6 b could be joined together using ultrasonic welding, a snap-fit,a press-fit, adhesive bonding, external fasteners, or any other suitabletechnique, whether now known or hereafter developed.

With continued reference to FIGS. 1A-B and 3A-B, handle 5 also includesa slot or recess 2 which receives a weight 30. Weight 30 serves toimprove the balance of the handle 5 when the two shells 6 a, 6 b arejoined together to receive the introducer needle 3. Preferably, weight30 is chosen so that when the surgeon holds the assembly in his hand,the needle 3 rests horizontally and the needle tip 4 does not press downor up. In other words, the assembly should have neutral balance.

Alternatively, a surgeon may prefer a different, non-neutral weightbalance, in which case the weight 30 could be selected accordingly.

As explained in detail below, the handle 5 may latch on and off of theintroducer needle 3, preferably using the pushbutton release 9 on thehandle 5, or, alternatively, via a smooth snap-on detent (not shown)that provides an audible “click” and/or a tactile confirmation when theintroducer needle 3 is snapped into or out of the handle 5. The handle 5is preferably removable because once the introducer needle 3 has beenused to introduce the implant member 1 into the patient's body, it maybe easier for the surgeon to separate the introducer needle 3 from theimplant member 1 once the handle 5 has been separated. Also, adetachable handle 5 could be suitably sterilized and reused, which willreduce expenses.

As depicted in FIGS. 3A-B, 4A-B and 5A, the lower shell 6 b of thehandle 5 has a central slot 25 at its distal end designed to accepteither end 4 of a symmetrical introducer needle 3′, or the slightlysmaller blunt end 16 b of an asymmetrical introducer needle 3, whichends are dimensioned to fit closely through the slot 25, and provides asolid, secure attachment for the needle. The distal end of the handle 5also may be tapered so as to effectively increase the working length ofthe introducer needle 3.

The handle 5 has internal structure arranged to accommodate andcooperate with a latch mechanism 33, as shown in FIGS. 1B, 3B, 4A and4B. As best seen in FIGS. 3B and 4A, the latch mechanism 33 has a biasedand pivotable elongated latch member 35 with a projection 39 whichengages the opening 27 in the end 4 of the introducer needle 3. When thehandle 5 is assembled as shown, the latch mechanism 33 securely holdsthe end 4 of the introducer needle 3 until the operator chooses torelease the end 4 of the introducer needle 3 by pressing the button 9 onthat latch mechanism 33.

As shown in FIGS. 1B, 3B and 4A, the elongated latch member 35 isreceived in the lower shell 6 b of handle 5. The latch member 35 has anend catch section 37 with a triangular or rounded projection 39 that issized and positioned to engage the opening 27 in the end 4 of theintroducer needle 3 (in the case of the asymmetric needle, the blunt end16 b). As previously explained, and with reference now to FIGS. 6A and6B, by making the two spatulated sections 13 of the introducer needle 3differ in size and shape somewhat and by enlarging the needle end 16 awhich passes through the patient's tissue and which is sharper than theother blunt end 16 b, the internal structure of the handle 5 can receiveonly the smaller blunt end 16 b of the introducer needle 3. Thisprevents erroneous insertion of the sharper end 16 a of the introducerneedle 3 into the handle 5. Whereas the blunt end 16 b of the introducerneedle 3 received in the handle 5 has a generally rectangular shape, theend 16 a of the introducer needle 3 that first passes through thepatient's body has a triangular shape suitable for dissecting tissue asit advances. Also, the blunt end 16 b of the introducer needle 3received in the handle 5 has a width W that is narrower than the widthW′ of the other end 16 a. Again, this difference is size and shapebetween the two ends 16 a, 16 b prevents misinsertion of the introducerneedle 3 in the handle 5.

A further benefit of this arrangement is that the differing appearancesof the flat, spatulated sections 13 provides a visual cue which helpsthe surgeon determine how to mount the introducer needle 3 in the handle5.

With reference now to FIGS. 3B and 4A, moving in the proximal directionaway from the end catch section 37, the elongated latch member 35 has apair of projecting rounded pivot arms 41 which serve as pivots that restupon part of the internal section of the lower handle shell 6 b, and apushbutton 9. The end 43 of the elongated latch member 35 locatedfurthest from the end 4 of the introducer needle 3 curves downwardtoward the bottom of the lower handle shell 6 b so that this end portionis bent when the elongated latch member 35 is held in the assembledhandle 5. Bending the curved end 43 of the elongated latch member 35generates a biasing force, which in turn is transferred via the roundedpivot arms 41 to the end catch section 37, thereby urging the projection39 downward and toward the opening 27 in the end 4 of the introducerneedle 3. This downward force keeps the projection in the slot formed inthe needle tip, and thereby secures the needle tip 4 in the handle 5.Preferably, the curved end 43 generates a progressive resistance toapplied force, so that as force applied to the elongated latch member 35increases, further pressing of the pushbutton 9 becomes more difficult.

Alternatively, as shown in FIG. 5A, a separate spring 32 such as ahelical spring can be mounted beneath the pushbutton 9 to opposeinadvertent downward movement of the pushbutton 9. As shown in FIG. 3B,this spring 32 also could be used with the curved end 43, for example,in case during the sterilization process, the curved end 43 permanentlydeforms, which would otherwise limit the force that such a curved end 43could apply (other types of springs such as a leaf spring also could beused). This way, the introducer needle 3 is securely held in the handle5 until release by the user.

Those skilled in the art will appreciate that as depicted in FIGS. 1 B,3B and 4A-B, the handle 5 which receives elongated latch member 35 hassuitably-shaped internal contours to accommodate the various structuralcomponents of the elongated latch member 35 and introducer needle 3.Other schemes for securing the introducer needle also could be used.

Another preferred embodiment of a handle 5 in accordance with thisinvention will now be described with reference to FIGS. 5A and 5B. Inthis embodiment, handle 5 includes an insert 12 having a slot 14 whichis dimensioned to accept the blunt end 16 b of the introducer needle 3.This insert 12 is preferably made of a durable and dimensionally stablematerial which does not yield or abrade under the stresses applied andconditions experienced during use of this invention, and thereby servesto reinforce the handle 5. The insert 12 also adds weight to the handle5 and helps to counterbalance the weight of the introducer needle 3 whenthe introducer needle 3 is joined to the handle 5. Preferably, theweight of the insert 12 matches the weight of the introducer needle 3 sothat the device balances evenly in the surgeon's hand. By way ofnonlimiting example, the insert 12 could be made from a machined ormolded piece of stainless steel, aluminum, alloy metal, high-densityplastic or other suitable material that has been suitably sterilized.

Each shell 6 a, 6 b of the handle 5 has an internal structureconstructed to hold the insert 12 securely; by way of non-limitingexample, the insert 12 has several recesses 18 which are dimensioned anddisposed to receive posts 45 formed in the lower shell 6 b of the handle5. When the upper and lower shells 6 a, 6 b are joined together, theposts 45 and recesses 18 cooperate to hold securely the insert 12 inposition.

In the embodiment depicted in FIG. 5A and 5B, the elongated latch member35 is biased by an abutting spring 32 so that the projection 39 pressesdownward into the slot or opening 27 formed in the tip of the introducerneedle 3. As shown, the spring 32 presses the portion of the elongatedlatch member that is proximal to the projecting rounded arms 41 upward,and so the elongated latch member rotates about the projecting roundedarms 41 so that the distal end 37 of the elongated latch member 35,which has the projection 39 engaging the slot 27 formed in the end 4 ofthe introducer needle 3, is pressed downward toward the introducerneedle 3.

It will be appreciated that the spring 32 or another suitable biasingmember could be placed in a different location, for example, on theother side of the elongated latch member 35 in the area above and acrossfrom the projection 39.

To release the introducer needle 3 of any of the foregoing embodiments,the operator depresses the button 9 into the handle 5 with forcesufficient to overcome the biasing force of the curved section 43 of theelongated latch member 35 and/or the pressing applied by the spring 32to the elongated latch member 35. The button 9 pivots downward about theprojecting rounded arms 41, and the projection 39 is raised upward andout of the opening 27 in the introducer needle 3. The introducer needle3 then can be withdrawn from the handle 5.

It will be appreciated that the shape of the projection 39 is such thatwhen, as shown in FIG. 3B, a introducer needle 3 is inserted into thehandle 5, the surface of the projection 39 rides up onto the flat,spatulated section 13 of the end 4 of the introducer needle and isdisplaced upward above the advancing introducer needle 3. The introducerneedle 3 continues to advance inward until the tip 4 of the introducerneedle 3 reaches the end of the chamber dimensioned to accommodate theintroducer needle 3, and the opening 27 in the introducer needle 3 ispositioned beneath the projection 39, at which point the projection 39is forced downward into the opening 27 through the urging force exertedby the curved section 43 of the elongated latch member 35. Now, theintroducer needle 3 is securely joined to the handle 5, as depicted inFIGS. 3A-B and 9A-C.

Also by way of non-limiting example, pushbutton 9 and the opening 26 inthe top shell 6 a in which it is received are arranged so that thebutton surface is flush with the handle 5, and is positioned so thatwhen the surgeon grasps the handle 5, the pushbutton 9 falls between thesurgeon's fingers. This helps to avoid inadvertent release of theintroducer needle 3 from the handle 5.

Furthermore, the elongated latch member 35 is preferably constructed sothat it only releases the introducer needle 3 when the pushbutton 9 isfully-depressed; until then, the introducer needle 3 remains securelyheld in the handle 5. This way, a slight depressing of the pushbutton 9from routine handling will not trigger release of the introducer needle3. Furthermore, the opening in which the pushbutton 5 sits is contouredso that if the pushbutton 9 is inadvertently pressed by a hand or fingercovering that opening, the introducer needle 3 is not released. Thesetwo features combine to reduce the likelihood of accidental introducerneedle release.

All of these features combine to render it unlikely that a surgeon couldinadvertently depress the pushbutton 9 while grasping the handle 5.

By way of non-limiting example, the upper and lower shells 6 a, 6 b ofhandle 5 are preferably manufactured by injection molding using asuitable plastic material. Any other suitable manufacturing technique,such as machining of a plastic or metal blank, also could be employed.

It will be appreciated that the dimensions and configuration of thehandle shell 6 a, 6 b and any internal structure, such as the elongatedlatch member 35, should be selected so that the handle 5 can withstandthe loads and torques experienced during use to advance introducerneedle 3 and position the implant member 1.

The present invention also envisions the use of a handle 5 andintroducer needle 3 which have been permanently joined together.

As part of the present invention, the introducer needle 3 and the“T”-shaped handle 5 are used to position the implant member 1 in thepatient's body. This requires the needle 3 to be joined to the implantmember 1. This is accomplished using a dual-ended connector 7, such asthat shown in FIGS. 7A-D, 8A-G, 9A-D and 10. Such connectors 7 provide apermanent, snap-fit connection between introducer needles 3 and theimplant member 1, and thereby ensure secure connection between thosecomponents during passage into the patient. “Permanent” means that it isnot intended to be separated and so it would be difficult to manuallyseparate a connector 7 from the introducer needle 3 or the implantmember 1 after they have become permanently affixed (it does not,however, require that it be impossible to separate those parts). Byproviding a permanent connection, there is also less of a chance that aconnector 7 could be left behind in the patient's body followingcompletion of this procedure.

The ergonomically-designed handle 5 also could be straight, or acombination of straight and T-shaped for optimum grip during both theabdominal and vaginal approaches. A T- shaped handle 5 may be generallypreferred by doctors for a vaginal approach, while a straight handle(not shown) may be generally preferred for an abdominal approach, and soa handle 5 which allows for both types of grips may be preferred andmore practical. It will be understood that the precise manner in whichthe surgeon grips the handle 5 is a matter of individual preference, andthat the gripping techniques disclosed herein are by way of non-limitingexample.

Next, a number of different needles in accordance with this inventionwill be discussed.

With reference now to FIGS. 5A-B and 6A-B, the flat, spatulated section13 of the needle end 4 is adjacent to a flared region 47. This flaredregion 47, owing to its size and profile, facilitates passage of theintroducer needle 3 into the patient's body, and, after the implantmember 1 has been joined to the introducer needle 3 by a connector 7,also facilitates withdrawal of the introducer needle and accompanyingintroduction of the connector 7 and attached implant member 1 into thepatient's body. Preferably, seen in a direction perpendicular to thedirection along which the needle end 4 is advanced into the body (thelong axis of the introducer needle 3), the flared section 47 is somewhatlarger in cross-section than the cross-section of the connector 7 thatcan be attached to the needle end 4. The connector 7 rides easily behindthe flared section 47. Further, the shapes of the connector 7 and theflared region 47 are complementary.

The present invention contemplates the use of needles with and withoutthe flared section. Examples of needle with the flared section can beseen in FIGS. 2, 3A-B and 4A-B. A needle having a flared section refersto a needle having a cross section at a given position such that theconnector which follows the needle rides in the “shadow” of that givenarea. In other words, the width of the given area in any particulardirection is at least as large as the width of the connector in the samedirection. As discussed in detail below, the present invention disclosesuse of a needle having a flared section; seen in an end view, each pointon the perimeter of the largest portion of the flared section lies on oroutside of the perimeter of the largest portion of the connector whichis drawn along by the needle.

Testing has showed that far less resistance is encountered over theconnector 7 and implant member 1 when using a needle having the flaredsection, as compared to the use of a needle without such a flaredsection (not shown). A puncture test was conducted through a layer ofporcine abdominal fascia using both types of needles. Whereas the needlewith the flared section required 2.7 lbs. of force to penetrate throughthe fascia, the other type of needle required 3.2 lbs. of force topenetrate the fascia.

A second test was performed to evaluate the force over the connector 7and implant member 1 after the initial opening was made. The testconsisted of pulling each needle assembled with the connector 7 andimplant member 1 through a layer of porcine abdominal fascia in asimulated-use test fixture. This test simulated the clinical use of thedevice being pulled through the rectus fascia or endopelvic fascia of apatient. The peak force measured using the needle without a flaredsection was 3.6 lbs., whereas and the peak force using the needle withthe flared section and connector was 1.2 lbs.

For the needle without the flared section, the force to pull theconnector 7 and implant member 1 through (3.6 lbs.) is higher than theinitial penetration force (3.2 lbs.). For the needle having the flaredsection 47 and the connector 7, the force to pull the connector 7 andimplant member 1 through (1.2 lbs.) is substantially lower than theinitial penetration force (2.7 lbs.).

The general shape of needles which can be used with this invention willnow be described.

As depicted in FIG. 2, the introducer needle 3′ can be curved anddouble-ended. Each end 4 of the introducer needle 3 can interchangeablyaccept either the handle 5 or a connector 7 to be described. The curvedcentral portion 11 of the introducer needle 3 is preferably circular incross-section, although other cross-sectional profiles such aselliptical, hexagonal, square or triangular also could be employed. Thecurvature of the central portion 11 is sufficient to enable closetracking along the posterior surface of the patient's pubic bone betweenthe abdominal and vaginal incisions. Consequently, it may be preferableto provide a range of different introducer needles, collectively sizedto cover a range of different patient body sizes.

Each end 4 of the double-ended introducer needle 3′ is spatulated with athin, flat design to provide clean and atraumatic dissection, ratherthan cutting or piercing, of the patient's tissue during insertion.Because these two ends 4 have the same shape, each of the needle ends 4can interchangeably engage either the handle 5 or a connector 7. Eachend 4 of the double-ended needle 3′ has a generally-arcuate centralsection 11 leading to a tip region having a flat, spatulated section 13.The size and precise shape of the spatulated section 13 can be selectedto reflect the patient's anatomy. Preferably, the introducer needle 3′(or 3) is shaped to allow close tracking along the posterior surface ofthe pubic bone, keeping the needle tips 4 in the “zone of safety”. The“zone of safety” is, generally, the area behind the posterior surface ofthe pubic bone between the upper and lower edges of the pubic symphysis.This area is relatively free of vasculature and other organs that couldbe damaged if the needle 3 were deviated too far posteriorly orlaterally.

The flat, spatulated ends 4 provide a solid mounting surface forengagement with a slot 25 in the handle 5 by distributing the forcesencountered during the procedure over a wide area inside the handle 5.Such forces may include compression, torque, bending and tension. Therounded needle tips 15 also serve to minimize unwanted perforations ofthe bladder and other vessels, while at the same time allowing theneedle to gently dissect the patient's tissue as the needle advancesinto the patient's body. Although here the ends 4 of the introducerneedle 3′ are preferably the same size and shape, this invention is notto be so limited; as already explained, different size and shape endsalso could be provided.

It also will be appreciated that the length, curvature and tiparrangement of the introducer needle 3′ all affect the manner in whichthe introducer needle 3′ tracks during use, and that this invention isintended to cover all such arrangements.

By way of non-limiting example, a curved introducer needle 3 accordingto this invention can subtend an obtuse angle, i.e., 98° , and have abend radius of 4.7 inches, or can subtend a right angle, 90°, and have a3.4 inch radius, or can subtend an acute angle, i.e., 60°, and have a3.3 inch radius.

Again, all of these dimensions have been given by way of example onlyand not limitation. Other dimensions also could be used.

Also optionally, and with reference now to FIGS. 5A-B, the portion ofthe introducer needle 3 leading to the flat spatulated sections 13 couldbe straight, so that a straight section 20 is located between the curvedsection and at least one of the needle ends 4. Such straight sections 20are presently thought to be of particular use with an introducer needle3 having a right angle bend, and also could be used with other needleconfigurations.

By way of nonlimiting example, and with reference to FIGS. 5A-C, theintroducer needle 3 can be constructed with an asymmetric geometry suchthat the curved section 22 is provided near the distal end, and theportion of the introducer needle 3 located between the surgeon and thecurved portion 22 is longer than the portion of the introducer needle 3projecting forward from the curved portion 22. This arrangement providesadded working length at the proximal end of the introducer needle 3,which improves handling, while the shorter segment at distal end of theintroducer needle 3 can better conform to the pubic bone as it advances.The increased length of the proximal end of the introducer needle 3 alsopermits the use of a longer handle 5, which may allow for more precisepositioning of the introducer needle 3.

Presently, it is thought to be preferable to round the needle ends 4 formaximum safety. However, the ends could be sharp-edged or even pointedto facilitate penetration through the fascial layers during insertion.

Each end of the introducer needle 3 has an opening or slot 27therethrough. As depicted in FIGS. 2 and 6A-B, the openings 27 arepreferably rectangular, although other shapes, such as circles, ovals,squares and triangles also could be employed. More than one opening 27also could be provided in each end 4. These openings 27, as will beexplained in greater detail below, are used to join one end 4 of theintroducer needle 3 to a handle 5, and also to connect the other end 4of the introducer needle 3 to the implant member 1.

The introducer needle 3 can be made of any suitable biocompliantmaterial such as stainless steel. If desired, the introducer needle 3could be coated with a low-friction layer of material (not shown) suchas polytetrafluoroethylene to reduce insertion trauma.

Optionally, and with reference now to FIG. 5D, the introducer needle 3could be provided with a shrink-tubing sleeve. Such a sleeve would servetwo purposes; first, if made of PTFE (Teflon®) or similar material, itcould provide a very lubricious surface to ease passage of theintroducer needle 3 through the body, while at the same time preventinginjury to the body tissue. Secondly, the sleeve could be made in a verybright color such as green or blue to improve visibility during acystoscopy to confirm bladder integrity. Even if bladder perforation isnot observed, the bright color of the sleeve can be seen through thethin bladder wall confirming safe placement of the introducer needle 3.

As depicted in FIG. 5D, the sheath is tubular, with open ends; however,it will be appreciated that the distal end of the sheath could be closedto further facilitate advancement of the introducer needle 1 into thepatient's body. If desired, the closed end of the sheath could be cutoff once the sheath has entered and passed through the patient's body,for example, when it protrudes through an abdominal incision.

With reference now to FIG. 13, the connector 7 is used to obtain apositive, snap-fit connection between the introducer needle 3 and theimplant member 1 to ensure secure attachment during passage of theintroducer needle 3 and the implant 1 into the patient. Preferably, theconnector 7 is flexible, and permanent. Several different embodiments ofconnectors according to this invention now will be described.

To minimize tissue trauma during use, all of the surfaces of theconnector 7 are preferably tapered and/or rounded, and have alow-friction surface. The connector 7 can be made from a low-friction,biocompatible material, and, if desired, can be surface treated orcoated to improve its properties.

To further minimize tissue trauma, it is preferable to have, as depictedin FIGS. 9A-D and 15A-C, the tips of the arms of each connector 7 whichabut the flat, spatulated section 13 of the introducer needle 3 beshaped to conform to the tapered end 4 of the introducer needle 3 (inother words, these parts have complementary shapes). Preferably, theends of the connector 7 that abut the flat, spatulated section 13 of theintroducer needle 3 have flexible tips that conform snugly to the end 4of the needle 3. Also, the arms of the connector are preferably longenough so that they cover much of the flat, spatulated section 13 of theintroducer needle end 4 and come close to the flared region 47 of theneedle end 4.

FIGS. 7A-D depict a first embodiment of a connector 7 having limitedflexible construction. This design allows for the connector 7 to pivotand bend freely about certain axes during passage into the body(rotation around the locking projection 57 and bending at the mid jointor web 51) to better follow the curved path created by the introducerneedle 3.

Connector 7, as shown in FIGS. 7A-D, is symmetrical about a verticalplane. Each side of the connector 7 is designed for attachment to eitherthe introducer needle 3 or the implant member 1, and, since theconnector 7 is symmetrical, the two sides are interchangeable. Thismeans the surgeon, when joining the connector 7 to the introducer needle3 or implant member 1, does not have to spend time choosing a particularside of the connector 7 for attachment.

In this connector 7, the two lower arms 53 a, 53 b on each side of theconnector 7 are joined directly to a central web 51. Each arm 53 a, 53b, 55 a and 55 b can have a narrower region 56 which serves as a livinghinge. The living hinges 56 could be molded directly or formed bymachining portions of the arms 53 a, 53 b. The projections 57 extendingupward from the lower arms 53 a, 53 b toward opposing upper arms 55 aand 55 b, respectively, are generally cylindrical in shape (and, morepreferably, are frusta-conical), with a flared end cap 59. Openings 61are formed at positions opposite to the projections 57. Each opening 61has a beveled inner surface 63 dimensioned to receive the end cap 59 ofthe associated lower arm 53 a, 53 b, and at least one slot 65. The slot65 allows the beveled inner surface 63 of the opening 61 to deformsufficiently to receive and allow passage of the flared end cap 59. Oncethe flared end cap 59 passes completely through the opening 61, thedeformed inner surface 63 of the opening 61 returns to its normalposition, and the flared end cap 59 cannot be retracted therethrough.Although the flared end cap 59 may project somewhat from the flat backsurface of the upper arm 55 a or 55 b, the rounded shape of the flaredend cap 59 means it still will pass smoothly through the patient'stissue during insertion of the implant member 1.

FIGS. 7C and 7D show the connector 7 when each pair of upper and lowerarms 53 a, 53 b, 55 a and 55 b are respectively brought together andlocked by engagement of the flared end cap 59 with matching openings 61.

FIGS. 8A and 8B show an alternate embodiment of a connector 107 that issimilar to the connector 7 just described. In this arrangement, only theupper arms 155 a and 155 b of the connector 107 are bendable aboutnarrower regions 156 serving as living hinges. The lower arms 153 a, 153b are fairly rigid, owing to their thickness and the lack of hingeareas, and they lie in a plane. A central web 151 extends upwardperpendicular to the plane in which the lower arms 153 a, 153 b lie, andthe upper arms 155 a, 155 b are attached to this central web 151. Asshown in FIG. 8B, the upper arms 155 a, 155 b are joined to the centralweb 151 by living hinges 156. Here, frusta-conical projections 157extend from the upper arms 155 a, 155 b toward the opposing lower arms153 a, 153 b, which have matching openings 161 formed therein. Connector107 is preferably made from a biocompatible polymeric material. Tosimplify manufacture and use, the connector 107 is preferably formed asa molded integral unit, but also could be made from separate componentssuitably connected.

Also alternatively, the connector 107 could be machined in its entirety.

As shown in FIG. 8A, each opening 161 has a beveled inner surface orcountersunk portion 163 and counterbored portion 164, for reasonsdescribed below.

The end of the projection 157 has a flared end cap 159 which is sizedand positioned to engage and cooperate with the beveled edge 163 of theopposed opening 161. Preferably, at least one slot 167 is formedextending through the projection 157. This way, when the arm 153 a, 153b is moved toward the opposing arm 155 a, 155 b, the beveled surface 169on the end of the projection 157 strikes the beveled edge 163 of theopening 161, urging the divided portions of the projection 157 towardeach other. As the divided portions of the projection 157 move inward,they can pass between the edges of the opening 161, until the halves ofthe projection 157 extend outward from the bottom surface of theelongated lower arms 155 a, 155 b. The halves of the projection 157 arereceived in the counterbored portion 164 of the opening 161. Thecounterbored portion 164 is preferably dimensioned so that the flaredend cap 159 does not project outward from the upper arm 153 a, 153 b.This way, the connector 107, when closed, still has a smooth,projection-free outer surface which is easily drawn through thepatient's tissue during implant member insertion.

The halves of the projection 159 then spring out and engage the backsurface of the lower arms 155 a, 155 b, and prevent the projection 157from being drawn back through the opening 161.

Accordingly, the connector 107 shown in FIGS. 8A and 8B provides a morerigid structure than the previous connector 7, and may be preferred inview of a particular patient's anatomy, or in view of the surgeon's ownpreferences.

FIGS. 9A-C depict yet another embodiment of a connector 207 similar tothat shown in FIGS. 7A-D. In the embodiment depicted in FIGS. 9A-C, eachpair of arms 253 a, 253 b, 255 a, 255 b has two, rather than one,projections 257, each projection 257 again having a flared end cap 259.The opposing arm 253 a, 253 b, 255 a, 255 b has openings 261 sized andlocated to receive and securely hold the flared end caps 259. As before,the arms 253 a, 253 b, 255 a, 255 b are attached by living hinges 256 ormore flexible sections, to a central web 251. The tip portion 271 ofeach arm 253 a, 253 b, 255 a, 255 b is tapered in thickness, and the tipportions 271 all are angled slightly to approach one another. Thisslight inward bend at the ends of the connector 207 helps provide acompressed, snug fit when snapped onto the introducer needle 3 orimplant member 1. This way, when the connector 207 is joined to theimplant member 1, the tip portions 271 of the arms 253 a, 253 b, 255 a,255 b squeeze the implant member 1 somewhat. The tapered shape of thetip portions 271 also facilitates movement of the connector 207 throughbody tissue.

The use of two projections 257 in each side of the connector 207provides several benefits. First, it improves the strength of thesnap-lock by distributing the loads over the greater area of the twoprojections 257. Second, the dual projection design improves theconnection to the implant member 1 by distributing the forces over twoholes in that member, instead of one. Third, the dual projection designprevents rotation/pivoting of the connector 207 on the needle 3. Thismay help prevent “kinking” of the connector 207 on the needle 3 if themovement of the introducer needle 3 is reversed. However, the connector207 may still flex in the center about the central web 251 along thelongitudinal direction to better conform around the curved pubic boneduring passage.

The dual projections 257 used in the connector 207 shown in FIGS. 9A-Cprovide stronger connections between the implant member 1 and theconnector 207 and the introducer needle 3 and the connector 207, andthey redundantly protect against failure of any one projection 257.Also, using two projections 257 prevents rotation of the implant member1 or introducer needle 3 about those projections 257 (in the case of theintroducer needle 3 the projections 257 are preferably received in anelongated slot 27 just able to accommodate the projections 257), whichcould happen if a single projection were to be used. This may prevent orat least reduce “kinking” of the connector 207 or the implant member 1during placement in the body.

Although FIGS. 9A-C show that the projections 257 for one pair of arms253 a, 253 b, 255 a, 255 b are located so as to extend upward and theprojections 257 of the other pair of arms 253 a, 253 b, 255 a, 255 bextend downward (in other words, the projections 257 face in oppositedirections), it will also be understood that the projections 257 couldbe positioned so that they face in the same direction.

FIG. 9D depicts a further refinement of the connector 207 shown in FIGS.9A-C. While the two connectors 207 are generally the same in appearance,the connector 207 shown in FIG. 9D has, in addition to each pair of arms253 a, 253 b, 255 a, 255 b having two projections 257 and matchingopenings 261, a set of opposing and interlocking teeth 273 a, 273 bdimensioned and disposed to mate when the connector arms 253 a, 253 b,255 a, 255 b are brought together. These teeth 273 a, 273 b can improvethe connector's bite into the implant member 1. On the introducer needle3, these teeth 273 a, 273 b mesh together inside the slot 27 and helpprevent improper closure of the connector 207 on the introducer needle(which now has a single elongated slot 27 that allows integration withboth the connector 207 and the handle 5).

As shown, the upper arm 255 a on the left side has a single tooth 273 a,and the facing lower arm 253 a has two teeth 273 b. In this embodiment,when the connector 207 is closed, the one tooth 273 a of the left upperarm 255 a fits between the two teeth 273 b of the left lower arm 253 a.When such a connector 207 is joined to the implant member 1, these teeth273 a, 273 b will bite into and thereby capture the implant member 1.However, when the connector 207 is joined to the needle end 4, which hasan elongated slot 27 therein, the teeth 273 a, 273 b will just closetogether without any material therebetween.

FIGS. 10 and 11A-B depict still another embodiment of a connector 207 inaccordance with this invention. This embodiment is substantially similarin configuration to the connectors 207 shown in FIGS. 9A-D, but differsin that the teeth 273 a, 273 b of FIG. 9A have been replaced by a“+”-shaped boss or projection 275 (it should be understood that anyother suitable shape boss also could be used, such as a hemispherical orcylindrical boss in place of the “+”-shaped projection 275). The“+”-shaped projection 275 is located on one of each of the two arms 253a, 255 a or 253 b, 255 b making up each side of the connector 207. Asshown in FIGS. 11A and 11B, the “+”-shaped projection 275 does notextend all the way from one arm to the other - rather, the “+”-shapedprojection 275 is about half the height of the gap between the opposingarms 253 a and 255 a or 253 b and 255 b. When the opposed arms on eitherside of the connector 207 are squeezed together, the “+”-shapedprojection 275 limits how close together the opposing arms 253 a and 255a or 253 a and 255 b can be pressed. As shown in FIG. 11B, which depictsthe “+”-shaped projection 275 being formed as part of, and extendingupward from, the lower arm 255 b, if the two opposing arms 253 b, 255 bare pressed together by sufficient force, the upward-facing “+”-shapedprojection 275 strikes the upper arm 255 b and prevents furthercompression. This keeps the two arms 253 b, 255 b separated by theheight of the “+”-shaped projection 275. When the connector 207 isattached to the implant member, the separation maintained between thetwo arms 253 b, 255 b, becomes the height of the boss plus the thicknessof the implant member.

The “+”-shaped projection 275 also helps to prevent improper connectionto the introducer needle 3; for example, while a connector 7 such asthat shown in FIGS. 7A-B could be connected sideways to an introducerneedle 3, here the “+”-shaped projection 275 will interfere with theneedle 3 unless both of the connector's cylindrical projections 257 arealigned with the slot 27 in the needle 3.

It will also be appreciated that the “+”-shaped projection 257, since itlimits inward movement of the facing arms 253 a, 255 a and 253 b, 255 b(“oversnapping”), also can control the pressure that the arms 253 a, 255a and 253 b, 255 b apply to an implant member 1 held therebetween. Thismay avoid unnecessary material damage.

Preferably, the “+”-shaped boss 275 has rounded and blunt surfaces, andit does not bite or clamp down on the implant member 1. Accordingly,this structure should not be viewed as a tooth.

FIGS. 51A and 51B show yet another connector configuration. Thisconnector 307 has a pair of upper and lower jaws 353 a, 353 b, 355 a,355 b which are linked together by a length of flexible tubing 377. Thelength and stiffness of the tubing 377 can be chosen according to theproperties required for the connector 307. Each upper and lower jawsection has upper and lower jaws 353 a, 355 a which come together at oneside of a center body 351, and a barbed connector 379 located on theother side of the center body 351. The barbed connector 379 isdimensioned so that when it is inserted into the flexible tubing 377,the barbed connector 379 secures the upper and lower jaw sections 353 a,355 a against backward movement.

With reference now to FIGS. 6A, 6B, 14A, 14B and 15A-C, aspects of thisinvention are depicted in which the needle tip 4 and the connector 7 aredesigned with complementary shapes such that the advancing introducerneedle 3 passes through the tissue prior to movement of the connector 7therethrough, as will now be described (FIGS. 14A-B depict the connectorof FIG. 9D but, for simplicity, the numbering of connector 7 has beenemployed). The needle 3 has a flared section 47 that, when seenperpendicular to the needle's axis, extends over at least the same areaas the connector 7, and, more preferably, over a somewhat wider areathan the connector 7. The flared section 47 precedes the connector 7 andimplant member 1 through the tissue. The flared section 47 therebyreduces the amount of force required to create the implant passageway.As the passageway is created by the introducer needle 3, the connector 7and implant member 1, which are attached to one end of the introducerneedle 3, follow the needle into the tissue channel. The connector 7 andimplant member 1 are “shadowed” by the flared section 47 of theintroducer needle 3 during passage through the tissue. This way, thetissue channel is formed without substantial trauma to the patient'stissue, and the tissue channel is large enough so that the connector 7and implant member 1 can pass through without causing injury to thetissue and without difficulty.

As depicted in FIGS. 12, 17A-D and 20A-E, the implant member 1 is anelongated strip of material about 30-50 cm long and 1-2 cm wide. In theembodiments shown in FIGS. 12, 17A-D, 20A and 20C-E, the implant member1 has a center section 81 flanked by arm portions 83 a, 83 b.Preferably, the implant member 1 is symmetrical. In many cases the armportions 83 a, 83 b include slits 85 that improve the implant membersanchoring properties, whereas the center section 81 does not have suchslits. Alternatively, the edges 87 of the arms 83 a, 83 b could besmooth, scalloped, or even have irregular shapes formed thereon. Thetips 89 of the arm portions 83 a, 83 b are rounded, and each tip 89 hasone or more openings 91 therein, the purpose of which will be discussedelsewhere.

The center section 81 is preferably dimensioned so that, when theimplant member 1 is positioned in the patient's body, the center section81 helps to distribute force in the region of the urethra in a manner toprovide a backboard or support that enables urethral closure whenabdominal pressure increases occur.

In one embodiment of this invention, each of the arm portions 83 a, 83 bpreferably has a length sufficient so that when the implant member 1 isfirst implanted in the manner discussed below, the tips 89 of the arms83 a, 83 b protrude outward from the patient's body. Thus, the arms 83a, 83B should be sized for use with the largest patients likely toundergo this procedure. The protruding tips 89 of the arms 83 a, 83 bcan be manipulated by the surgeon to properly position the implantmember 1, and also to apply the desired amount of tension to the implantmember 1.

Given these dimensional considerations, it may be preferable to providea range of different sized implant members to better accommodate thephysiologies of different sized patients. Implant member width, thelength of the center section 81 and of the arms 83 a, 83 b all could bevaried to provide a number of different implant members 1. Implantmember shape and dimensions can be selected according to the holdingforce desired.

The arms 83 a, 83 b of the implant member 1 shown in FIGS. 12, 13 and22A have “sawtooth” or “wave” shaped outer edges 87. This arrangementwill help anchor the implant member 1 in the patient's tissue, and willsecure the implant member 1 against unwanted movement.

Other possible edge styles that allow for easy insertion in the tapereddirection, but that also resist movement in the opposite directioninclude uniform “saw-tooth” edges 87 and smooth curved edges 87. Eachedge style can either be deep or shallow to generate higher or loweramounts of self-anchoring force. The edges 87 can also have numeroussmall slits 93 to help generate additional anchoring ability andpossibly more adjustability in the surrounding tissue throughout-of-plane deformation of the material between the slits 93, asdiscussed in greater detail below. By way of further non-limitingexample, a plain, straight-edged implant member 1 also could be used,whether of constant width or having a different width in the region ofthe urethra.

An implant member 1 having an irregular edge 87 could support a greaterforce than an implant member 1 having a straight edge 87. Largerserrations should provide better holding power, but cannot be adjustedin position as easily; the serrations or projections 95 act as“ratchets”, and a finely pitched ratchet, it will be appreciated, can beadjusted more precisely.

By way of non-limiting example, one configuration of the implant member1 is a 10-15 mm wide strip with directional texturing about 1-2 mm deepon each side. The spacing between each peak of the edge texture (the“teeth”) 95 is preferably in the range of 2-10 mm. This spacingcharacteristic can provide maximum adjustability (an analogy is to abelt—closer spaced holes in the belt allow smaller and more preciseadjustments). Also, the implant member 1 is preferably 30-50 cm inlength, and has an untextured center section 81 approximately 1-15 cmlong, with 2-10 cm being more preferable. Arm widths of 12 mm and centersection widths of 15 mm may be preferred.

It should be understood that as the number and size of the projections(teeth) 95 increase, the force which the implant member 1 can withstandalso increases.

In one embodiment, the projections 95 on the edge of the implant member1 could be 1.5 mm deep, 6 mm apart in pitch, and the implant member 12mm wide at its widest portion. Again, these dimensions are exemplary,and other dimensions also could be used.

The use of inner slits 85, rather than sawtooth-shaped outer edges 87,may be preferred because an implant member 1 with inner slits 85 may beeasier to position than an implant member with sawtooth-shaped outeredges 87. By virtue of the slits' shape, the implant member 1, as it isintroduced into the patient's body, slides easily through tissue, sincethe low force required to pull the implant member 1 behind the flaredsection 47 of the introducer needle 3 means that the internal slits 85will lie flat in the same plane as the rest of the implant member 1, andwill not interfere with insertion of the implant member 1.

The use of “V”-shaped slits 85, as depicted in FIGS. 17A, 17C, 17D,18A-B and 19A, and others, is presently preferred. Implant members 1constructed in this manner have a dynamic and centrally-locatedself-anchoring design. The self-anchoring design has series of V- shapedslits 85 (preferably identical in size and shape) arranged along thecentral axis of the implant member 1. These V-shaped slits 85 are cut ineach arm 83 a, 83 b of the implant member 1 and point towards the centersupport section 81 of the implant member 1.

Unlike systems which rely on statically-formed geometry, such as thesaw-tooth edges 87 discussed above, to create the self-anchoring force,this configuration incorporates a dynamic self-anchoring system whichdevelops a progressively-increasing anchoring ability that providesgreater resistance to movement the more the implant member 1 isstressed. By using a soft, natural tissue material, the implant member 1can deform easily when subjected to the stress and tension encounteredduring implantation. As tension is applied, the implant member 1stretches and buckles causing expansion and opening of the slits 85 toallow the surrounding patient tissue to compress inward through theimplant member 1. As the applied tension increases, the slits 85 beginto deflect outward to create a progressively greater anchoring force.The greater the deflection, the greater the surface area contacting thepatient's tissue, and the better the anchoring force. If, however, anexcessive amount of stress or tension is applied, the slits 85 buckleinward allowing the implant member 1 to slide gradually through thepatient's tissue. This helps minimize the possibility that too muchanchoring force will be generated by the implant member 1.

This self-regulated anchoring design creates the dynamic ability toprovide a progressive anchoring force for the implant member 1. Thestatic geometry-based systems cannot develop this progressive anchoringability because the self-anchoring features are fixed in a single,static position. As a result, their functionality and ability toself-adjust to the tension being applied is limited.

As an added benefit of the centralized self-anchoring design, all edgetexturing can be eliminated, leaving smooth, straight edges on theimplant member 1. This may be helpful because edge texturing can createadditional drag during implantation (i.e. a higher implantation force isrequired) which could cause additional trauma to the surrounding tissue.By centrally locating the self-anchoring mechanism on the implant member1, there is almost no drag generated by the slits 85. The anchoringforce is only generated when the direction of tension on the implantmember 1 is reversed, exactly as is desired during clinical use of theimplant member 1 as a sling.

With reference to FIGS. 17A and 20A-E, it should be noted that theV-shaped slits 85 on one side of the implant member 1 face in theopposite direction from the slits 85 on the other side of the implantmember 1. This is done because the implant member 1 is introduced in thepatient's body one arm at a time, with each arm 83 a, 83 b being drawnupward from beneath the area of the patient's urethra into thesuprapubic space toward the abdomen. Thus, it is the direction in whicheach arm 83 a, 83 b of the implant member 1 advances into the bodyduring placement that determines slit orientation.

In contrast to the foregoing implant member configuration, an implantmember 1 having outer sawtooth-shaped edges 87, as shown in FIG. 12 willbe more difficult to position, because the sawtooth-shaped outer edges87 of the implant member 1 will tend to resist any movement, whetherforward or backward. To some extent, this resistance to movement can becontrolled by altering the shape of the sawtoothed outer edges 87—bysuitably tapering the teeth 95 so that, moving from the proximal end ofthe tooth 95 to the distal end of the tooth 95, the tooth 95 narrowsinward, resistance to rearward movement can be increased and resistanceto forward movement can be decreased.

Further, as shown in FIGS. 15A, 15C, 17A-D, 18A-B, 19A-E, 20A-E; 22A-Fand 24A-C, internal slits 85 or perforations could be provided in atleast some portion of the implant members arms 83 a, 83 b to allow thepatient's tissue to fold into the interstitial spaces formed by thoseslits 85 or perforations. This arrangement also facilitate tissueingrowth, and increase strip flexibility, much like synthetic mesh.

Alternate designs for the dynamic, self-anchoring slits 85 can beenvisioned. In these other designs, the shape of the slits 85 isaltered, for example, with an arrow design (essentially a V having abisecting slit in the middle of the V), a semicircular slit design, arectangular slit, etc. all could be used. Some of these otherconfigurations will later be discussed in detail.

By way of non-limiting example, the internal slits 85 could be V-shaped,arrow-shaped, curved, round, oval, square, triangular or irregular, andthey could be arranged in a straight line, as depicted in FIGS. 19A-Eand 22C-E, or in patterns such as rows, checkerboards, diagonal lines,or even randomly, as shown in FIGS. 24A-C and 26A. A range of differentsize and pattern slits or perforations 85 could be used in a singleimplant member 1, and the internal perforations also could be combinedwith various edge details, or could be used alone to vary the anchoringproperties of the implant member 1.

Different arrangements of slits 85 could be combined with differentimplant member shapes. The middle urethral support section 81 can eitherbe straight-edged tissue without holes, or it can be continuouslytextured over the full length of the implant member 1. In addition, themiddle urethral support section 81 could be wider than the textured arms83 a, 83 b of the implant member 1 to provide a larger support areaunder the urethra. The present most preferred option is astraight-edged, uniform width, non-textured support section 81 to helpalleviate any concerns over erosion from the texturing details. In themiddle of the urethral support 81, a small hole 97, visible in FIGS.17A, 17B, 20A and 20C-E, or notches on the edges (not shown) could beprovided to help identify the center of the implant member 1 for evenpositioning under the urethra. As shown in FIG. 17C, inwardly-pointingtriangles 97′ also could be used to define the center part of theimplant member 1. Alternatively, a dye mark (not shown) could be madeacross the center.

For example, FIG. 20A shows an implant member 1 of uniform width havingV-shaped slits 85 disposed along its centerline that is presentlypreferred. A center region 81 of the implant member 1 does not have suchslits, however, so that it can better support the patient's tissue.Also, this embodiment has a hole 97 formed at its center in order tohelp the surgeon determine when the implant member 1 has been properlypositioned. Each arm 83 a, 83 b has two openings 91 formed at its tip89, and these openings 91 receive the projections 157 of a connector 107such as that shown in FIG. 9D. This arrangement also could be used witha connector 7 having a single projection 57 on each side, as shown inFIG. 8A. Alternatively, these holes could be omitted and they could beformed by the surgeon using a blade or scissor, or they could even beformed when the connector arms 53 a, 53 b, 55 a, 55 b are closedtogether, the projections 57 serving as punches.

In contrast, the implant member 1 depicted in FIG. 20B has slits 85along its entire length—here, the surgeon can identify the center of theimplant member 1 by looking for the region where the V-shaped slits 85change their orientation. This configuration may allow for greatervariation in the placement of the implant member 1 in the patient'sbody.

The implant member 1 shown in FIG. 20C is generally similar to thatdepicted in FIG. 20A, differing in that the central section 81 of theimplant member 1 is wider than the arms 83 a, 83 b. Again, the centralsection 81 is solid, save for a central opening 97 that helps indetermining when the implant member 1 is properly placed. The widercenter section 81 provides additional support for the patient's urethra.

The implant member 1 shown in FIG. 20D has a solid center section 81with a central positioning opening 97 and arms 83 a, 83 b that are widerthan the central section 81.

The implant member 1 depicted in FIG. 20E is similar to that shown inFIG. 20A, but the arms 83 a, 83 b are shorter in length. The shorterarms 83 a, 83 b anchor primarily in the endopelvic fascia. An implant ofthis length also could be implanted without the need for an abdominalincision. Also, this implant member 1 could be used with extensionsattached to the tips 89 of the arms 83 a, 83 b, as will be discussedlater in this description.

With reference now to FIGS. 18A-B, the V-shaped slits 85 formed in theimplant member 1 allow easy implantation of the implant member 1 in theforward direction, and the implant member 1 has a lower resistance topull-through than a strip having sawtooth-shaped edges. FIG. 18A showsthe implant member 1 in the free state, without any tension appliedthereto. The slits 85 are closed and, when seen from the side, theimplant member 1 is flat. However, as shown in FIG. 18B, when tension isapplied along the length of the implant member 1, the slits 85 open sothat portions of the implant material extend outward from the plane ofthe implant member 1.

With reference now to FIGS. 21A and 21B, the lateral edges 87 of theslits 85 press against the surrounding fascia and tissue, providing asecure anchorage from which to suspend the implant member 1. When seenin the front view of FIG. 21A, the implant member 1 is substantiallycurved and compressed at the position where it passes through thetissue. However, the portions above and below the tissue through whichthe implant member 1 passes are uncompressed, and the tension applied tothe implant member 1 causes the slit regions to open up. The portions ofthe implant member 1 defined by the slits bend outward and, as seen inFIG. 21B, interfere with the tissue and increase the implant membersresistance to backward movement.

A similar design that is easy to pull forward but which resists rearwardmovement is depicted in FIGS. 26A-B. In this embodiment, the implantmember 1 has a pattern of V-shaped slits 85 formed on its surface not ina line, but rather, over substantially the entire area of the implantmembers arm 83. When in the untensioned state shown in FIG. 26A, theslit portions lie flat. However, when tension T is applied to theimplant member 1, as can occur during implantation or thereafter ifthere is an abdominal pressure increase, and as shown in FIG. 26B,portions of the implant member 1 project outward and will help to anchorthe implant member 1 in the patient's tissue.

FIGS. 26C-E show other embodiments of an implant member 1 similar tothat shown in FIGS. 26A-B, differing with regard to the shape andarrangement of the slits 85. It should be noted that the implant member1 shown in FIG. 26C has a line of triangular internal openings 86, aswell as two adjacent lines of V-shaped slits 85.

FIGS. 22B-F and 24A-C show implant members 1 having internal openings86. As shown in FIGS. 22C-F, these openings 86 can be circular,triangular or rectangular, or even irregular (not shown). The openings86 shown in FIG. 22C-F are arranged along a line parallel to the centeraxis of the implant member 1, while the openings 86 shown in FIG. 22B,24A and 24C are arranged over substantially the entire width of theimplant member 1. While the implant members 1 shown in FIGS. 22B-E and24A have irregularly shaped outer edges 87, and the implant members 1shown in FIGS. 22F, 24B and 24C have straight outer edges 87, it will beunderstood that the different opening shapes and arrangements can beused with either straight or irregular outer edges 87 as is desired. Inother words, and by way of nonlimiting example, the implant members 1shown in FIG. 22C could be produced with straight outer edges 87, andthe implant members 1 shown in FIGS. 24B and C could be produced withsawtooth shaped outer edges 87.

It should be understood that although the designs depicted in FIGS.17A-D, 18A-B, 19A-E and 20A-E all have a single row of slits 85, thisinvention is not to be limited to that arrangement. Multiple rows ofslits 85, random arrangements of slits 85, and a combination of rows ofslits 87 and a random arrangement of slits 85 all could be employedwithout departing from the present invention.

In a design having centerline openings 86 disposed along the length ofthe implant member 1, such as the design depicted in FIGS. 23A-B, thetissue will tend to fold over on itself during implantation, creatingmultiple ridges at the centerline of the implant member 1, helping toanchor the implant member 1 in the patient's tissue. Owing to thegeometry of the openings 86 openings in this embodiment, the implantmember 1 can easily advance into the patient's tissue, but when in place“locks” and resists rearward tension.

Different opening shapes also could be combined; as depicted in FIG.26C, the implant member 1 could have both triangular openings 86arranged along its centerline, along with triangular surface slits 85arranged laterally to the centerline openings 86, and smooth edges 87for smooth and easy implantation. The triangular openings 86 andtriangular slits 85 operate in the manner already discussed to resistrearward tension.

Also by way of non-limiting example, an embodiment of an implant member1 having straight edges 87, yet having improved anchoring properties, isshown in FIGS. 25A-C. As depicted therein, the implant member 1 has aseries of angled, inward-extending slits 93 arranged preferably on bothof the implant members edges 87 (it will be appreciated that only oneside of the implant member could be provided with such slits 93). Withreference to FIG. 25A, when tension is not applied to the implant member1, the edges 87 of the implant member 1 lie flat. However, as seen inFIGS. 25B and 25C, when the implant member 1 passes through thepatient's tissue and tension is applied to the implant member 1, theedges 87 of the implant member 1 having slits 93 deform and flareoutward and “lock” into the tissue, resisting the tension being applied.The implant member 1 “locks” into the surrounding tissue because theslits 93 allow portions of the implant member 1 to fold out from themembers main body. As depicted in FIG. 25C, the portions that fold outextend into the patient's tissue, resisting backward force. Thisincreases the implant members resistance to backward movement.

As a further option, implant member 1 could have one or more openings 86formed in arm portions 83 a, 83 b. By way of non-limiting example, suchopenings 86 could be of geometric shape (i.e., round, square,triangular), or irregular, and could be arranged in a line, in apattern, or irregularly. Embodiments of such implant members aredepicted in FIGS. 22B-F and 24A-C. During implantation, the openings 86do not interfere with insertion of the strip. It will be appreciatedthat more than one opening shape could be used on a single implantmember 1, and that opening size and pattern could be varied to changethe strip's ability to resist backward tension. As discussed earlierwith regard to different slit arrangements, this invention is not to belimited to the configurations shown in the drawings. Multiple rows ofopenings, random arrangements of openings, and a combination of rows ofopenings and a random arrangement of openings all could be employedwithout departing from the present invention, for example, as shown inFIGS. 24A-C.

By way of non-limiting example, the openings 86 in the implant member 1shown in FIG. 24B could range in size from 0.25-3.0 mm.

The foregoing embodiments of this invention employ implant members eachmade from a single piece of material. This invention also envisionscomposite implant members that are assembled from several differentpieces of material.

FIGS. 27-28G depict a range of different composite implant members 101.Such implant members 101 can have a center section 181 made from onetype of material, such as natural material, and arms 183 a, 183 b madeof a different material, such as synthetic mesh, as shown in FIGS.27-28G. Among the benefits of this arrangement is the ability toconstruct each of these sections using material which has the requisiteproperties desired for the section where is used; the mesh arms 183 a,183 b can be self-anchoring, and the central natural material 181, ifpositioned under the urethra, reduces the potential for erosion andinfection.

The arms 183 a, 183 b can be attached to the center section 181 usingany suitable technique now known or hereafter discovered. By way ofnon-limiting example, FIGS. 27, 28C and 28D show mesh arms 183 a, 183 bpassing through slits 184 formed at the ends of the center section 181and doubling back over the body of the mesh arms 183 a, 183 b. The tipof the doubled section is then fastened to the body of the mesh section183 a, 183 b by any suitable attachment technique, such as suturing,heat-bonding, ultrasonic welding, adhesive, stapling or riveting.

As depicted in FIG. 28B and 28E, the mesh arm 183 a, 183 b can be joinedto the natural center section 181 using a rivet or snap-down connector188.

FIG. 28F and 28G show still another embodiment, wherein the end of thenatural material center section 181 is “T” shaped, the mesh arm 183 a or183 b is placed onto the cross-arm of the T, and the cross-arm of the“T” is folded back over the mesh arm 183 a, 183 b, and is then secured,for example, by suturing or adhesive.

While the foregoing implant member configurations are suitable forconnection to the introducer needle 3 by a separate connector 7, thepresent invention also contemplates that the implant members 1 could beconstructed with a suitable integral connector 407 for attachment to theintroducer needle. Such an implant member design allows the surgeon tocomplete the implantation procedure more rapidly, since there is no needfor the surgeon to join the implant member to the connector.

Such a connector 407 can be thought of as a “half connector, since italready is joined to the implant member 1 and only needs to be attachedto the introducer needle 3.

One example of an implant member 401 having integral connectors 407attached to the ends of the implant member 401 is shown in FIG. 39. Asshown, the ends 404 of the arm sections 483 a, 483 b have connectors 407respectively attached thereto. These connectors 407 serve to join theimplant member 401 to a needle (not shown), which is used to positionthe implant member 401 in the patient's body, as has already beendiscussed. This arrangement, it should be noted, is a composite, inwhich the central portion 481 of the implant member 401 is made of onematerial, such as biocompatible natural material, and the arms 483 a,483 b, to which the half-connectors 407 are joined, are made of adifferent material, such as synthetic mesh material.

Connectors 407 are generally similar in configuration and operation toconnectors 7, 107, 207 and 307 discussed above. They differ, however, inthat whereas the connectors 7, 107, 207 and 307 are double-ended,connectors 407 are single-ended. Thus, connectors 407 are jaw-like inappearance. A projection 452 at the base of the jaws 453, 455 isprovided for attachment to the arms 483 a, 483 b of the implant member401. The projection 452 can be attached to the arms 483 a, 483 b usingany suitable technique now known or later discovered. By way ofnon-limiting example, thermal bonding could be employed.

Also by way of non-limiting example, the projection 452 could be madefrom two shorter jaws (not shown) having a suitable locking mechanism,such as an interfering flanged projection in one jaw and a matingopening in the other jaw, and which can be squeezed together with thearms 483 a, 483 b therebetween to securely join the implant member 401to the projection 452.

The composite implant member 401 discussed above preferably has a middleurethral support section 481 that is about 7-8 cm long. This size is,however, mentioned only by way of example, and not limitation.

A number of other implant member configurations having integralconnectors will now be discussed.

As shown in FIG. 40, an elongated connector 507 with an integral strap540 is depicted. This connector 507 has lower and upper arms 553 and 555which are substantially similar in form and function to the connectorarms 253 a, 253 b, 255 a, 255 b shown in FIG. 9A-C. These arms 553, 555are integrally attached to one end of the flat strap/connector body 540having a plurality of holes 542 running therethrough (alternatively, theholes 542 could be omitted). The other end of the connector body 540 ispermanently attached to the arm portion 583 of the implant member 501(in practice, a connector 507 will be attached to each of the two endsof the implant member 1). As shown in FIG. 40, this connection is madeby suturing, but this invention is not to be limited to thatarrangement. Any other suitable attachment technique, whether now knownor hereafter discovered, could be used, such as, for example, adhesivebonding, ultrasonic welding, or mechanical interconnection using afastener such as a rivet. This connector 507 could be made by anysuitable manufacturing technique, such as molding.

Once the implant member 501 to which connector 507 is attached has beenproperly positioned, the exposed portion of the connector protrudingabove the patient's abdomen is removed by cutting the connector bodywhere it is exposed. This way, all of the implant member 501, and aportion of the connector 507, the holes 542 of which also contribute tothe anchoring function, remain in the body. If a very long implantmember 501 is used, it is conceivable the arms 583 a, 583 b of theconnector will be exposed and so would have to be cut to detach theconnector, although this would be less desirable insofar as implantmaterial would be wasted.

FIG. 41 depicts still another example of an elongated connector. Likethe embodiment shown in FIG. 40, this connector 507 also has lower andupper arms 553, 555. Such a connector 507 could be formed in anysuitable manner, such as by molding. These arms 553, 555 are integrallyattached to a generally cylindrical connector body 540 having aplurality of spherical or conical enlargements 544 disposed along itslength (other shapes also could be used). The precise shape and numberof enlarged regions 544 is not to be limited, and, if desired, theenlarged regions 544 could be omitted altogether. The other end of theconnector body 540 is enlarged and is permanently attached to the end ofthe arms 583 of the implant member 501. Again, this connection is shownas being made by suturing. Any other suitable attachment technique couldbe used, including the techniques just described above.

Again, once implant member 501 is properly positioned in the body, theexposed portion of the connector protruding above the patient's abdomenis removed by cutting the connector body where it is exposed. All of theimplant member 501, and a portion of the connector 507, the holes 542 ofwhich also contribute to the anchoring function, remain in the body. Asalready noted, if a very long implant member 501 is used, it isconceivable the arms 583 a, 583 b of the connector will be exposed andso would have to be cut to detach the connector, although this would beless desirable insofar as implant material would be wasted.

An alternate embodiment of an implant member 201 according to thisinvention will now be discussed in connection with FIGS. 29-38. Theimplant member 201 is intended to handle more easily than other implantmembers, while still applying the required force to the body tissuebeing supported. As will now be explained in detail, this implant member201 is preferably made of natural material, and is processed to improvethe material's physical properties.

Among the materials which can serve as supports in female urinaryincontinence sling suspension procedures is acellular porcine dermaltissue. Such dermal tissue material must, however, be processed torender it biocompatible. One scheme for preparing biocompatible porcinedermal tissue is set forth in U.S. Pat. No. 5,397,353 to Oliver et al.and owned by Tissue Science Laboratories PLC. Such material iscommercially available as Pelvicol™ implant material, distributed byC.R. Bard, Inc. of Murray Hill, N.J. and produced by Tissue ScienceLaboratories PLC, of Aldershot, Hampshire, United Kingdom.

The material described in the '353 patent is particularly preferable foruse in the present invention because such material is non-antigenic andis recolonized and revascularized by the host tissue. Also, thismaterial, owing to cross-linking, is non-resorbable, meaning it is notprocessed and eventually absorbed by the patient's body. Consequently, asupport made from this material will provide permanent support, and incontrast to a procedure using a support made from resorbable material,the patient will not have to undergo later surgery to replace thesupport. It should be understood that other types of natural materialsalso could be used.

Advantageously, Pelvicol™ implant material has omnidirectional strengthproperties. Further, Pelvicol™ implant material does not shed particlesunder load, as mesh material does. In this invention, the Pelvicol™implant material is specifically designed to provide for optimumanchoring and adjustability in the rectus fascia at the abdomen and/orthe endopelvic fascia near the urethra. These two tissue layers providethe majority of the anchoring force around the implant by virtue of thedense fibrous nature of the fascia. Based on simulated use testing, thePelvicol™ implant material creates an anchoring force that is comparableto and, in some cases, even better than that generated by pure syntheticmesh implanted in the fascia.

FIGS. 29 and 30 show in close-up how a slitted piece of processed dermaltissue 224 can expand in response to applied force.

As depicted in FIG. 29, implant member 201, which is incorporated into asuitably-shaped sling, as discussed below, includes a number of slits285 formed therein. Implant member 201 can be a flat piece of acellulardermal tissue 224, preferably, porcine, prepared in accordance with the'353 patent. Because no tension is being applied to implant member 201,slits 285 remain closed due to the inherent elasticity of the materialfrom which implant member 201 is made.

Implant member 201 has a length (not shown in full in FIGS. 29 and 30)running in the direction of axis Y, a width W extending in the directionof axis Z, and thickness T in the direction of axis X.

The thickness T is of interest because it affects how the material“handles”; a thin piece of material will be more supple than a thickerpiece of material, and so the thin piece of material can better conformto the patient's anatomy. A thin piece of material may not, however, beable to support all loads applied. This means that the thickness of thematerial should be selected so that the material is sufficientlyflexible, yet is also strong enough to support all forces that it may besubjected to.

By way of non-limiting example, the preferred thickness T i s about0.8-2.0 mm; thinner material can be used but, depending upon the loadapplied, may deform excessively or even fail. Consequently, materialthinner than about 0.8 mm preferably will not be used in mostcircumstances. Thicker material also can be used, although it should beunderstood that material greater than 2.0 mm may be too thick because itmight be noticeable to the patient, and also might be so stiff that itis difficult for the surgeon to work with. Here, material thicker thanabout 2.0 mm preferably will not be used in most circumstances.

The implant member 201 is preferably between 0.5-3 cm. in width (W),and, more preferably, between 1-2 cm. in width. When choosing the widthof the implant member 201, the patient's body size and the amount offorce likely to be required can be taken into account. Higher forcelevels may require the use of a wider or thicker implant member 201.

The implant member 201 extends in length along the direction of axis Y.Preferably, the implant member 201 is between 20-40 cm., morepreferably, between 30-40 cm., and even more preferably, 30 cm long whenin the tension-free state.

It also will be appreciated that the implant member 201 could be trimmedas needed, whether because of the patient's anatomy or because less thanthe full amount of the implant member material is needed.

With continued reference to FIG. 29, the slits 285 formed in the implantmember 201 are preferably arranged in a regular and repeating pattern.By way of non-limiting example, the slits 285 can be about 3.7 mm inlength. As can be seen, the slits 285 in the implant member 201 areformed in rows that run in the direction of axis Z and which rows areparallel to the length of the implant member 201. Slits 285 are arrangedin a “row” where those slits 285 are all line segments which lie on asingle line. The slits 285 are preferably arranged in a staggeredfashion; as shown in FIG. 29, alternating rows of slits 285A and 285Bare placed so that, moving in the direction of axis Y along the lengthof the implant member 201, the slits in rows 285A do not lie directlyadjacent to and in registry with the slits in rows 285B. Instead, movingalong axis Y from a slit 285 in any given row 285A one then encountersthe solid material between the slits 285 in the adjoining row 285B andthen the slit 285 in the next row 285A that follows the row 285B. Theslits 285 can be arranged so that the slits 285 in alternating (ratherthan adjacent) rows are disposed in registry. Staggered also can beconstrued more broadly to mean that the rows of slits 285 are arrangedin any manner such that a slit 285 in one row does not lie alongside andin complete registry with a slit 285 in an adjacent row, meaning partialoverlap of slits 285 is permitted.

Optionally, the ends 289 of the implant member 201 could be rounded foreasier implantation.

The arrangement and quantity of slits 285 will affect the properties ofthe implant member 201. As the number and/or length of the slits 285increases, the implant member 201 will stretch more under a given load.An implant member 201 having a large number of slits 285 will be morepliable than an otherwise identical implant member having a lower numberof slits, but the former implant member 201 may not be as strong becauseof the greater number of slits 285.

So too, slit size can be varied to control the elastic properties of theimplant member 201. As larger slits 285 are formed, the implant member201 will stretch more under a given load, and will not be able towithstand as large a maximum load before failing.

This configuration provides the anchoring benefits which can be obtainedwhen synthetic mesh is used, without the possibility of tissue abrasion,which can occur with synthetic mesh.

The slits 285 can be formed in the source material 224 using a skingraft mesher (not shown). Skin graft meshers are known and are currentlyused in connection with the treatment of burns. These devices allow askin graft of a particular size to be expanded so as to cover a greaterarea wound. Skin graft meshers are described in U.S. Pat. No. 5,004,468,U.S. Pat. No. 5,219,352 and U.S. Pat. No. 5,306,279, all assigned toZimmer, Inc., of Warsaw Ind., and U.S. Pat. No. 6,063,094, assigned toL.R. Surgical Instruments Ltd. of Ofakim, Israel. These devices use oneor more bladed cylindrical cutters and a support carrier to produce anarray of slits in the skin graft. The meshing ratio, also known as aslit ratio, (i.e., 1.5:1, 3:1 or 6:1) refers to the approximate amountby which the graft expands; for example, a 1.5:1 meshing ratio providesa graft that covers approximately 1.5 times the area of the originalgraft. Different cutters are used to produce different mesh ratios. Ingeneral, as the mesh ratio increases, so does the number (or length) ofslits that are formed in the graft.

Presently, a Zimmer Skin Graft Mesher is preferred. This device ismanufactured by Zimmer, Inc.

The present invention encompasses the use of slit ratios up toapproximately 6:1.

Alternatively, the slits 285 could be formed using a suitable die, oreven by hand-slitting the source material 224 with a blade. Othercutting techniques, such as water jet or laser beam, also could be used.

A slit ratio of 1.5:1 is presently preferred because it results in animplant member 201 having both good strength and extensibility. As notedabove, the slit ratio refers to the approximate amount by which the areaof the resulting meshed graft is increased. A 1.5:1 ratio grafttherefore will cover approximately 150% of the area of the source graftprior to meshing. Ratios of 3:1 and 6:1 also could be used, dependingupon the amount of force that will be applied to the implant 201. Indeciding which meshing ratio to use, it should be understood that highermeshing ratios, while they allow the use of less material, result in amore elastic implant member 201 which may have difficulty supporting themaximum loads likely to be encountered. By way of non-limiting example,using a piece of material 224 of the preferred length of 30 cm., aftermeshing that material 224 could be expanded under tension toapproximately 45 cm.

As an alternative to slits 285, and as shown in FIGS. 22B-F, holes 86could be formed in the implant member 1. Holes 86 may enhance wounddrainage (and so reduce wound dehiscence), but the elastic properties ofthe resulting implant member 1 would not be the same. Also, unlike slits285, where virtually no material is removed from the implant member 201,to form holes 86 it is necessary to remove (and so waste) material fromthe implant member 1, since the holes 86 must be formed by punching theimplant member 1 with a die or cutter.

As a further alternative, slits 285 and holes 286 could be arranged in agenerally alternating manner to insure the benefits of the slits 285 arestill available.

With reference now to FIG. 30, the depicted implant member 201, whichincludes an array of slits 285, is under tension from force applied inthe direction of arrow F. The applied force, which is preferably spreadover the ends of the implant member 201 in generally uniform fashion,causes the slits 285 to open. The open slits 285 result in expansion ofthe implant member 201 by approximately its meshing ratio.

While the implant member 201 is under tension, the slits 285 defineopenings 285’. Openings 285′ provide at least two benefits. First, someof the patient's tissue may extend into at least some of the openings285′, and that can increase the friction between the implant member 201and the patient's body. Depending upon the manner in which the implantmember 201 is placed in the body, owing to this increased friction, itmay not be necessary to suture the implant member 201 into place.Second, over the course of time, tissue will grow into the openings285′, and that will help to secure the implant member 201 into place inthe patient's body. Such ingrowth differs from ingrowth into themicrostructure of the implant member 201; here, tissue will actuallyenter into and grow through the open slits 285 (openings 285′) of theimplant member 201 (which is not to say that tissue also cannot growinto the microstructure of the implant member 1). Second, fluid exchangethrough the implant member 201 is enhanced, since fluid and suspendedand dissolved materials can pass through the openings 285′.

The precise shape of the openings 285′ will be determined by both thelength of the associated slit 285 and the magnitude of the force that isapplied. Seen in the direction perpendicular to the Y-Z plane of FIGS.29 and 30, the openings 285′ are approximately lens-shaped. In practice,the shape of the openings may differ without departing from thisinvention.

An embodiment of this invention particularly suitable for use as thesupport in a urethral sling suspension procedure is depicted in FIGS.31-33.

As shown in FIGS. 31 and 33, implant member 201 has an unmeshed centralregion 281 free of any slits. A first perforated arm region 283 a havingslits 285 is located on one side of the central region 281, and a secondperforated arm region 283 b having slits 285 is located on the otherside of the central region 281. Consequently, the central region 281 isdisposed between the perforated regions 283 a, 283 b. FIG. 33, it willbe appreciated, depicts the implant member 201 of FIG. 31 when tensionhas been applied thereto, so that the slits 285 open up.

As shown in FIGS. 32A-B, slits 285 are arranged in rows running acrossthe width of the implant member 201. The slits 285 in these rows can bedisposed in the manner described above in connection with FIGS. 29 and30.

When introduced into the patient's body, the implant member 201 ispositioned so that the central region 281 is located beneath andapproximately centered with respect to the patient's urethra.

Because the central region 281, which does not have any slits, lies inthe vicinity of the patient's urethra, the solid portion 281 of theimplant member 201 can provide greater support for, and help distributeforce over, the patient's urethra. Also, the smooth surface of the solidportion 281 may be less likely to irritate the urethral tissue than itwould if slits were formed therein.

To aid the surgeon in positioning implant member 201, a small circularhole 297 can be formed at approximately the center of the central region281. Alternatively, a colored dot or line, or any other suitable visualor tactile indicia, could be provided. This way, the surgeon can easilyposition the implant member 201 by arranging the implant member 201 sothat the opening (or colored region) 297, or other center indicator, islocated beneath or at least near the urethra.

In addition, the implant member 201 can (but need not) have one or moreopenings 291 formed at each of its tips 289. These openings 281 canserve as attachment points for an introducer needle or a connector suchas that already described and shown in FIGS. 9A-D, which can be used toplace the implant member 201 into the patient's body in the manneralready described. While FIGS. 31 and 33 depict two openings 291 at eachtip 289 of the implant member 201 to accommodate a connector 107 such asthat shown in FIGS. 9A-D, which has two projections 157, and so helpdistribute the forces which are applied to the ends 289 of the implantmember 201, just one opening 291 could be provided at each end, say, foruse with the connector 107 shown in FIGS. 8A-B. Alternatively, no holescould be provided, in which case the projections 157 on the arms 153 a,153 b, 155 a, 155 b of the connector 107 would, as the connector arms153 a, 153 b, 155 a, 155 b are pressed together with the implant member201 therebetween, pass through existing slits 285 in the implantmaterial 224, or would pierce solid portions of the implant member 201and form such holes.

FIGS. 32A-B show how the implant member 201 deforms and stretches inresponse to applied force F.

FIG. 32A shows the implant member 201, including slits 285, in therelaxed state. Owing to the inherent elasticity of the material 224 fromwhich implant member 201 is made, the slits 285 remain closed.

FIG. 32B shows the implant member 201 subjected to tensile force F alongits length. Such force F could be applied to each end 289 of the implantmember 201 over an area or at one or more discrete points; uniformloading is preferred because it is less likely to apply excessive stressto any particular portion of the implant member 201. The resultingdifference in shape between the unloaded and loaded implant member 201can be seen by comparing FIGS. 32A and 32B.

The tensile force F causes the slits 285 to deform and change shape toopenings 285′, which are approximately lens-shaped. Again, the preciseshape of the openings 285′ will depend upon the size and spacing of theslits 285 and the properties of the material 224 from which the implantmember 201 is made.

It will be noted that, under load F, the arm portion 283 a stretchesfrom length L₁ to length L₁′. The center portion 281 stretches from L₂to L₂′. The amount of stretching of the arm portion 283 a is greaterthan that for the central portion, 281, owing to the slits 253(accordingly, (L₁′)/(L₁)>(L₂′)/(L₂)) formed in the arm portion.

The applied tensile force F also may cause the implant member 201 to“neck-down” in width. By way of non-limiting example, it is thought thatan implant member 201 that is 2 cm. wide will, when loaded, narrow downto approximately 1.5 cm. in width. This is desirable because a strip 1.5cm. wide is thought to be the optimal size for use in the typicalpatient's anatomy. These dimensions are given by way of example and notlimitation, and it will be appreciated that other size implant membersalso could be provided.

The implant member 201 is preferably made from material 224 whichretains its elasticity, and so, when tension is not applied to theimplant member 201, the inherent resiliency of the material closes slits285.

The slits 285 can be distributed uniformly throughout perforated arms283 a, 283 b, as shown in FIGS. 31 and 33. Alternatively, the slits 285could be distributed in an asymmetric manner (not shown), for example,the implant member 201 can be formed with fewer slits 285 near thecentral region 281, and more slits 285 near the free ends 289 of themeshed arm section 283 a, 283 b. It is expected that with thisconfiguration, the strength of the implant member 201 beneath theurethra and flexibility of the meshed arm sections 283 a, 283 b will beincreased.

In some instances, it may be desirable to have the slits 285 in theimplant member 201 remain open even when tension is not applied. One wayto do this is by first forming the slits 283 in the implant member 201,applying tension to the implant member 201 to cause the slits 285 toopen and form holes 285′, and then, while the implant member 201 isstill under tension, applying cross-linking agent to, or carrying out across-linking treatment on, the implant member 201. This cross-linkingwill “set” the implant member 201 in its deformed shape so that evenwhen tension is no longer applied the implant member 201 will retain itsexpanded arrangement and holes 285′ will be maintained. Thiscross-linking can be effected in known manner, and so need not bedescribed in further detail.

With reference now to FIG. 35, another alternative embodiment of thisinvention is shown. In this embodiment, the implant member 301 is formedwith slits 385 throughout substantially all of the length of the implantmember 301. The ends 389 of the implant member 301 can be left unmeshedto facilitate attachment of the implant member 301 to the equipment usedfor placement of the implant member 301 in the patient's body. In FIG.35, the ends 389 of the implant member 301 have holes 391 for use inattaching the implant member 301 to the equipment used for placement.This embodiment has a single uniform portion 381 comparable to thecenter portion 281 of the previous embodiment. Because the portion ofthe implant member 301 underneath the urethra is meshed, tissue ingrownunder the urethra could be improved.

FIGS. 36 and 37 depict a further embodiment of this invention. In thisembodiment, the implant member 401 has an elongated portion 481 similarto that depicted in FIG. 35, as well as an enlarged portion 482 locatedat the center of the elongated portion 481. These drawings differ inthat FIG. 36 depicts an implant member 401 having attachments holes 491at its ends 489.

FIG. 37, which can be prepared by cutting off the tips of the arms 481,has no openings at its tips. Thus, the ends 489 of the implant member401 are meshed and do not have other openings for attachment; rather,some of the slits 485 are used as attachment points.

In each of these embodiments the elongated section 481 and the enlargedportion 482 have slits 485 formed therein. When tension is applied alongthe length of the elongated portion 481, the slits 485 open to formdiamond shaped openings or holes 485′. By applying tension to the sides480 of the enlarged portion 482, the slits 485 in the enlarged portion482 will open in the same manner. It will be appreciated that, owing tothe geometry of the implant member 401, it may be preferable to applyforce to the sides 480 of the enlarged portion 482 by attaching each ofthose sides 480 at one or more points to the patient's tissue, sincesuch force will serve to hold the slits 485 open and thereby providebenefits as set forth above.

Alternatively, the implant member 401 could be subjected to tension andthereby be deformed to open the slits 485 outside the body and thentreated to fix the implant member 401 in its deformed position. One wayto do this would be by a suitable cross-linking treatment, as alreadydiscussed.

The enlarged portion 482 is positioned and dimensioned to lie beneaththe urethra. Owing to the greater area covered by the enlarged portion482, the pressure applied to the patient's tissue in the vicinity of theurethra can be reduced, since the enlarged portion 482 distributes forceover a larger region.

This implant member 401 is thought to be particularly suited forcystocele repair procedures or other surgical procedures involving thesupport of body organs. If desired, the enlarged portion 482 can besecured in place for such a procedure by passing one or more suturesthrough the enlarged portion 482 into the patient's tissue, or using anyother suitable attachment technique now known or hereafter developed.

The enlarged portion 482 can be formed as an integral part of theimplant member 401 (the entire strip will be formed from a single pieceof suitable material) or can be attached to a separate elongated stripof material. The elongated portion 481 and enlarged portion 482 can bejoined together by suturing, biocompatible adhesive, or any othersuitable technique now known or hereafter developed.

As shown in FIG. 37, the enlarged portion 482 can include a circularopening 497 which visually assists the surgeon in finding the center ofthe implant member 401, in the manner already described above.

Although the foregoing embodiments of this invention employ acellulardermal tissue, and, more preferably, acellular porcine dermal tissue,this invention is not to be limited thereto. Any other suitablematerial, whether natural or synthetic, or even a combination thereof,can be used. Other examples of suitable materials that could be usedwith this invention include allografts, xenografts and autografts, andabsorbable and non-absorbable synthetic materials.

As a further alternate configuration, it may be desirable not to haveslits along the edges of the meshed sections so that the slits are onlyformed in the center of the implant member (not depicted). This willalter the elastic properties of the implant member. Also, one or moreregions not having any slits and running along the length of the implantmember could be provided. For example, the implant member could have anelongated rectangular region running parallel to the length of theimplant member, in the direction of axis Z (not shown). The rectangularregion could be arranged about the centerline of the implant member 1.If more than one rectangular region is used, they could be arrangedsymmetrically with regard to the longitudinal (as opposed to thetransverse) centerline of the implant member.

Although FIGS. 31-33 and 35-37 depict implant members 301 and 401 inwhich slits 385 and 485 are formed in lines parallel to the long axis ofthe implant member 301 and 401, respectively, this invention is notlimited to those arrangements. By way of non-limiting examples, all ofthe slits could be formed, parallel to one another, at any angle between0-180° to the implant members longitudinal axis.

Nor must all of the slits be arranged in parallel to each other. Withreference now to FIG. 34, and by way of non-limiting example, an implantmember 501 can be constructed having rows of slits 585A oriented at afirst angle and alternating with other rows of slits 585B oriented at asecond angle relative to the longitudinal axis of the implant member501. This results in a “herringbone” pattern of slits 585. Force will beapplied along the long axis of the implant member 501, represented byarrow L. Further, there may be other situations where it is desirable toapply force to the implant member 501 at some other angle. In that case,owing to the different orientations of the slits in rows 585A and 585B,the implant member 501 may have different tensile properties along itslength and width.

As a further variation, slits intersecting at right angles to form“+”-shaped slits could be arranged in a grid pattern (not shown). As astill further variation, in order to increase isotropy of the implantmember a second grid of “+”-shaped slits, rotated by 45°, could then beinterlaced with the first grid of slits (not shown). Other arrangementsof “+”- shaped slits, or other shapes of intersecting slits, also couldbe used. Such slits could be formed in a single pass usingcorrespondingly-shaped cutters or in multiple passes, with slits of oneorientation being formed in one pass, slits in another orientation beingformed in a different pass.

Another way to obtain an implant member with more uniform tensileproperties would be to form the slits in the implant member with arandom arrangement (not shown). Since the slits as a group are arrangedwithout any particular preferred direction, the resulting implant membershould not elongate in any one direction more than another (thispresumes the number of slits is sufficient to offset the effect of anyone slit).

Also by way of example only and not limitation, one side of the implantmember could be formed with more or larger slits than the other in orderto provide asymmetrical elastic properties (not shown). When placed inthe patient's body, the more heavily perforated portion of the implantember will expand to a greater degree than the other portion of theimplant member.

If desired, the slits also could be arranged in an asymmetrical pattern(not shown). This would affect the manner in which the implant memberexpands under tension.

Also by way of example only and not limitation, one side of the implantmember could be formed with more or larger slits than the other (notshown). Then, when placed in the patient's body, the more heavilyperforated portion of the implant member will expand to a greater degreethan the other portion of the implant member. In other words,differential slit arrangement can provide an implant member withasymmetric properties.

A random arrangement of slits also could be employed—since the slitsare, overall, arranged without a particular preferred direction, theresulting implant member should not elongate in any one direction morethan another, provided the number of slits is large enough so that theeffect of any one slit is not too great.

The implant member 301/401/501 prepared in this manner can be joined toan introducer needle using suitable connectors, whether separate orpermanently attached to the implant arms, in the manner discussedearlier, for example, and as shown in FIG. 38, which shows such animplant member 301/401/501 in the non-tensioned state. Each connectorcan be attached to the introducer needle, and then to the tip of one ofthe arms of the implant member, and the introducer needle can then beused to draw that arm of the implant member into position in thepatient's body.

Alternatively, a connector similar to that shown in FIG. 39 could bepermanently affixed to the tip of each arm of the implant member, in themanner discussed in connection with FIG. 39.

In a further embodiment of this invention, the implant member can atleast in part be contained in a sheath of flexible material (not shown)having suitable friction and porosity properties, such as PTFE(Teflon®). The flexible material can be joined to the implant material,connected by passing a suture around the sheath to squeeze the sheathand implant therein against the base of the connector, or the implantmaterial could “float” therein.

In still another embodiment of this invention, the implant materialcould be contained in the sheath and the sheath itself be pulled intoposition by the introducer needle attached thereto. Once in position thesheath could be removed, leaving the implant material exposed.

Turning now to FIGS. 13, 14A-B, 15A-C and 16A-D, the introducer needle3, connector 7 and implant member 1 according to the present inventionare shown in various stages of assembly. Those skilled in the art willappreciate that the following discussion can be applied to the differentembodiments of this invention which have been described.

FIG. 13 shows the introducer needle 3 securely joined at one end to thehandle 5. One end 89 of the implant member 1 is free, and the other end89 is joined to one end of the connector 7. As better seen in FIGS. 14Aand 16A, the other end of the connector 7 is being secured to the otherend 4 of the introducer needle 3. The projection 57 in the connector hasbegun to enter the opening 27 in the introducer needle end 4, as theupper arm 55 a has not yet reached its closed position.

FIGS. 15A-C and 16A-C show both sides of the connector 7 joining theintroducer needle 3 to the implant member 1.

Again, it should be noted that in order to minimize tissue trauma duringuse, all of the surfaces of the connector 7 are preferably taperedand/or rounded.

In some instances it may be desirable to reduce the amount of materialrequired to form the body of the implant member, the body of the implantmember being the portion of the implant member which remains in thepatient's body after the surgical procedure is completed to support thepatient's tissue.

For example, the processed natural material that can be used in implantslings such as that shown in FIGS. 31, 33 and 38 may be expensive, andso reducing the amount of material that is required will reduce the costof the implant member.

The present invention reduces the amount of material used to form thebody of the implant member by providing removable extensions made fromless expensive material at the ends of the implant member body. Theremovable extensions, which provide added working length duringimplantation, are long enough so that they allow the surgeon to positionand tension the implant member in the same manner as longer strips, andthese extensions then can be removed at the conclusion of the implantprocedure. Long-them anchoring still comes from the tissue implant.

While this aspect of the present invention is thought to be especiallysuited for use with processed natural materials, it is not to be limitedthereto. Any other suitable biocompatible implant material could beemployed.

One example of an implant member configuration having removableextensions on the sides of a central body is depicted in FIGS. 42-45. Inthis embodiment, the implant member 601 consists of a middle urethralsupport section 681 and two extension loops 690. The middle urethralsupport section 681 can be made of any suitable material, such as thematerials discussed earlier in connection with other embodiments of thisinvention. Presently, natural material is preferred, owing to itscompatibility with body tissue.

By way of non-limiting example, the middle urethral support 681 can beabout 30 cm. in length. Other size supports can be employed according tothe needs of any particular surgery.

The extension loops 690, each of which passes through two holes 691 inthe end 689 of the middle urethral support 681, can be made of anysuitable flexible material, whether natural or synthetic, monofilamentor multifilament, provided the selected material possesses suitabletensile strength, flexibility and biocompatibility. Presently, syntheticmaterials are preferred, and the extension loops 690 shown in FIGS.42-45 are tubes of polyurethane or suture material, and any othersuitable material also could be used. The loops 690 can be formed fromsolid filaments, intertwined braids or strands. If made from polymericmaterial, the extension loops 690 can be injection molded, extruded or,if multi-strand woven. If made from metal, the extension loops 690 canbe made from wire.

With reference now to FIGS. 42-43C and 45, one extension loop 690 isattached to each end 689 of the middle urethral support section 681through one or more holes 691 formed in the middle urethral supportsection 681. FIGS. 42, 43B and 45 show an embodiment in which the middleurethral support section 681 has two holes 691 lying on a lineperpendicular to the long axis of the implant member 601. FIG. 43Adepicts an embodiment in which the extension loop 690 passes through asingle hole 691 in the end 689 of the middle urethral support section681. FIG. 43C shows an embodiment in which the extension loop 690 passesthrough two holes 691 that lie on a line parallel to the axis of theimplant member 601. Presently, the use of two holes 691 at each end 689of the middle urethral support section 681 is preferred because theholes 691 better distribute applied loads than one hole 691. Thus, italso will be appreciated that more than two holes 691 could be providedat each end 689.

One of the benefits of the composite implant member 601 is that afterthe implant member 601 has been properly positioned in the patient'sbody, the connectors 607 and loops 690 can be detached, leaving only themiddle urethral support section 681 in place. This is beneficial becauseit reduces the amount of foreign material in the patient's body and soallows for faster healing of the tissue channel wound formed duringplacement of the implant member. Thus, it may be preferable for theholes 691 in the middle urethral support section 681 to be somewhatlarger in diameter than the extension loop 690 passing therethrough, sothat the loop filaments can slide through the holes 691 without binding,which will help during placement of the implant member 601 in thepatient's body. This also allow for easy removal of the extension loop690, as discussed below.

FIG. 52 is a side cross-sectional view showing how the implant member601 of FIG. 45 can be joined to a introducer needle 603 through a holeor slot 627 formed in the introducer needle 603.

The configuration depicted in FIGS. 42, 43B and 45 is may be preferredbecause, as shown in FIGS. 44A-B, when tension is applied to theextension loop 690, the implant member 601 changes shape from flat tosomewhat curved. The curved tip 689 of the implant member 601 forms atapered nose section that allows for easier implantation of the implantmember. The curving of the tip 689 of the implant member 601 alsoencourages flaring out of the slits 685 of the implant member 601, whichimproves the implant members anchoring ability.

One benefit of the embodiment depicted in FIGS. 42-45 is that it can bepositioned without the use of a separate connector, provided a suitableproper introducer needle 603 is employed. FIG. 53A-B depicts one exampleof such an introducer needle.

With reference now to FIGS. 53A-B, an introducer needle 603 that can beused to directly attach to the extension loop 690 of an implant member601 as shown in FIGS. 42-45. The introducer needle 603 has a centralbody section 611 that is generally circular or oval cross-section, and aspatulated section 613 just proximal of its tip 616. The spatulatedsection 613 and tip 616 are shaped to allow for the dissection of tissueby the advancing tip 616. The tip 616 also has a “T”-shaped cavity 634which receives the extension loop 690. As shown in FIG. 53A, theextension loop 690 passes into the cavity 634 through the short leg 634a of the “T”, and is then received in one of the two arms 634 b, 634 cof the T. The extension loop 690 is attached to the needle 603 prior topassage into the patient's body. The portion of the “T”-shaped cavity634 into which the extension loop 690 is placed will depend upon whetherthe extension loop 690 is to be positioned by advancing or retractingthe introducer needle 603. If the introducer needle 634 advances forwardto position the implant member 601, then the extension loop 690 isplaced in the proximal leg of the “T” 634 b, and if the needle isretracted backward to draw the implant member 601 into place it isplaced in the distal part of the “T” 634 c. To avoid movement of thecaptured extension loop 690, the “T”-shaped cavity 634 can be madeslightly narrower than the extension loop 690, so that when theextension loop 690 is placed into the “T”-shaped cavity 634 it iscompressed and secured in place.

FIGS. 46A-B and 54 show how the introducer needle 603 of FIGS. 53A-B isused. As depicted in FIG. 54, the introducer needle 603, with thefilament of the extension loop 690 held in the “T”-shaped cavity 634, isadvanced from an incision in the vicinity of the urethra behind thepubic bone and upward until it emerges from an abdominal incision. Asshown in FIGS. 46A-B, the extension loop 690 can then be disengaged fromthe “T”-shaped cavity 634 in the distal tip of the introducer needle 603and the introducer needle 603 then can be backed out of the retropubicspace, leaving just the extension loop 690 protruding from the patient'sabdomen. The extension loop 690 is then used to draw the implant member601 into position beneath the urethra. As shown in FIG. 47, theextension loops 690 and the central support 681 are dimensioned suchthat the extension loops 690 can be cut at any point and removed whilethe central support 681 remains beneath the abdominal wall, anchored inthe surrounding host tissue.

It should be noted that the extension loop 690 shown in FIG. 54 is longenough so that even when the end of the extension loop filament held inthe introducer needle 603 that protrudes up from the abdominal incision,the urethral support has not yet even been drawn into the patient'sbody. This way, the extension loops 690 can be placed in the patient'sbody and used to adjust the position of the implant member 601 after theintroducer needle 603 has been removed.

The surgeon then applies moderate tension to the two exposed extensionloops 690 to draw the urethral support 681 into position beneath thepatient's urethra and to apply the required amount of pressure to thepatient's tissue. At this point, the ends of the urethral support 681still do not protrude out of the body from the abdominal incisions, andthe proximal portion of the extension loops 690 remain within the body,as shown in FIG. 47. Alternatively, if a longer urethral support 681 isused, the ends of the support could protrude from the abdominalincisions.

It is now desirable to remove the extension loops 690 so that theabdominal incisions can be closed. To do this, each extension loop 690is cut at a single point, as shown in FIG. 57A. Since the filament isnow severed, when tension is applied to the associated connector (notshown), the filament is pulled out from the hole(s) 691 in the urethralsupport 681, as shown in FIGS. 57B-C, and is drawn outward from thepatient's body, the longer leg of the filament passing through theopening(s) 691 in the middle urethral support section 681 and out of thepatient's body.

It also will be appreciated that it is undesirable to cut both filamentlegs, because then it will be less convenient to draw out the portion ofthe filament that was isolated by the two cuts.

The introducer needle 603 and handle 605 shown in FIG. 54 can be joinedtogether permanently. By eliminating the latch mechanism of a movablehandle, cost can be reduced and the device construction simplified.

FIGS. 55-56C depict an alternative configuration of an introducer needle703 that can be used to draw an implant member having an extension loopinto place in the patient's body. As shown in FIG. 55, the introducerneedle 703 has a generally straight body portion 736 a leading to acurved portion 736 b. A handle 705 having a pushbutton 709 is located atthe proximal end of the body portion 736 a. A movable conical tip 738 islocated in at the distal end of the needle 703, and a rod 746 connectsthe conical tip 738 to the pushbutton 709. The pushbutton is biased byan elastic member such as a spring (not shown) so that it pulls themovable conical tip 738 backward toward the handle 705.

FIGS. 56A-C show how the movable tip 738 of the introducer needle 703 ofFIG. 55 is used to capture the extension loop 790 of an implant member701 like that shown in FIG. 45.

FIG. 56A depicts the movable conical tip 738 pulled backward into thetip of the curved portion 736 b of the introducer needle 703 under theinfluence of the elastic member, as just discussed. The movable conicaltip 738 preferably has at least one and more preferably two grooves 748running from its tip to its rear, and these grooves 748 receive thefilaments of an attached extension loop 690 (not shown). The conical tip738 also has an opening 750 on one side that leads to a larger internalrecess 754 (in other words, a finger blocks much of the opening 750 inthe side of the movable conical tip 738). The base of the conical tip isattached to a flexible rod 746, which in turn is connected to the biasedpushbutton 709.

Turning now to FIG. 56B, the movable conical tip 738 has been shiftedforward in position until almost all but the proximal end of the movableconical tip 738 projects forward from the distal end of the curvedportion 736 b of the introducer needle 701. The movable conical tip 738is shifted forward by depressing the pushbutton 709 in the handle 705with force sufficient to overcome the biasing member (not shown). Themovable conical tip 738 then advances so that the opening 750 in theside of the conical tip 738 is fully-exposed, and can now receive thefilament of the extension loop 690.

Once the filament of the extension loop 690 is received in the internalrecess 754 of the movable conical tip 738, the user can release thepushbutton 709. The biasing spring then retracts the movable conical tip738 back to its original position in the needle body 736. Because theopening 750 in the movable conical tip 738 is covered by the needle body736, the filament of the extension loop 690 cannot escape from theinternal recess 754. Also, the filament of the extension loop 690 liesin the grooves 748 formed in the side of the movable conical tip 738.

It is contemplated that this introducer needle 703 could be used forboth abdominal and vaginal placement of the implant member. In theabdominal approach, the introducer needle 703 is driven downward from anabdominal incision, behind the pubic bone, and out beneath the urethral.The movable conical tip 738 is then actuated by depressing thepushbutton 709 to move the rod 746 forward, advancing the movableconical tip outward, to capture the extension loop of an implant member.The introducer needle 703 is then retracted with the extension loopattached until the extensions loop emerges from the abdominal incision.The introducer needle 703 is disconnected from the implant member andthen the extension loop is drawn upward by the surgeon to pull themiddle urethral support into place. Then, the extension loop is cut andthe loop is removed. This procedure is repeated on the contralateralside of the body.

In a vaginal approach, the extension loop is first captured by theneedle tip 738 outside the body. Then, the introducer needle 703, withthe attached extension loop, is driven inward beneath the urethra andupward around the pubic bone, until the movable needle tip 738 andcaptured extension loop emerge from an abdominal incision. The extensionloop is then released from the needle tip 738 and the needle 703 iswithdrawn from the patient's body. Tension is applied to the extensionloop to draw support section of the implant member into the properposition. After that, the extension loop is cut and removed. Finally,the procedure is repeated on the contralateral side of the body.

FIG. 48 depicts a variation of the implant member shown in FIG. 45. Inthis embodiment, each extension loop 890 has a connector 807 located atits distal tip. This connector 807 has at its distal end movable lowerand upper arms 853, 855 which are in appearance and function the same asthe upper and lower arms of the connectors shown in FIGS. 9A-D. Theconnector 807 is joined at its proximal end to the filament of theextension loop 890. The precise manner in which the connector 807 isjoined to the filament will be described later.

FIG. 49 shows how an implant member 801 as depicted in FIG. 48 havingextension loops 890 can be positioned in a patient. This configurationis intended to be used with an introducer needle 803 which can beremovably attached to the handle 805, so that the handle 805 can be usedto guide the introducer needle 803 beneath the urethra, upward aroundthe pubic bone and out of the abdomen. If the introducer needle 803 usedis symmetrical, the handle 805 can then be attached to the portion ofthe introducer needle 803 protruding from the abdomen and assist thesurgeon in drawing the implant member 801 into the body.

With continued reference to FIG. 49, the connector 807 is attached tothe end 804 of an introducer needle 803 having an internal slot 827 inthe end 804 by bringing the lower and upper arms 853 and 855 together.At least one and preferably two projections 857 extend from one of thearms through the internal slot 827 and are received in a matchingopening(s) 861 in the other arm (not shown). Then, when the introducerneedle 803 is retracted backward toward the patient's abdomen, theimplant member 801 joined thereto by the connector 807 is drawn inwardinto place in the patient's body. The surgeon moves the implant member807 into its final position by selective tensioning the extension loops890. Once the implant member 801 is properly positioned, the extensionloop 890 is cut at one place and the extension loop 890 is detached fromthe urethral support portion (center section) 881 of the implant member801, which remains in place in the patient's body after the surgery iscomplete.

FIGS. 50A-B depict one exemplary construction of a connector 807 thatcan be used to join the filament of the extension loop 890 to the centersection 881. The connector 807 shown in FIG. 50A has a single projection857 and a matching hole 861 in the upper and lower arms 855, 853respectively, and a central web 851, to which the upper and lowermovable arms 855, 853 are joined by living hinges 856. The singleprojection 857 allows for some rotation of the connector 807 once it isattached to a needle. A clevis structure 858 is attached to the otherside of the central web 851. Then, as seen in FIG. 50B, the filament ofthe extension loop 890 is arranged to pass around the vertical post 860of the clevis structure 858. Preferably, the filament of the extensionloop 890 freely passes through the clevis 858.

FIG. 50B depicts an alternate connector 807 having two projections 857and matching holes 861, as well as a “+”-shaped projection 862. Theseaspects of this embodiment are similar in construction and function tostructure shown in FIG. 10, already described. The two projections 857prevent rotation of the connector 807 after it is attached to the needle(not shown). The clevis 858 used in this embodiment is the same as thatjust described with reference to FIG. 50A.

FIG. 50C depicts an alternative arrangement for joining the connector807 to the filament of the extension loop 890. In this arrangement, theconnector 807 has a central web 851 similar to that shown in FIGS.50A-B. In place of the clevis, however, there is a panel 866 having aflat wall 866′. The two ends 868 of the extension loop filament abut andare joined to the flat wall using any suitable known attachment scheme,such as press-fitting, adhesive bonding, ultrasonic welding or any othersuitable technique.

This configuration may be advantageous because the extension loop, whencut at a single point, remains attached to the connector 807, incontrast to the clevis arrangement of FIGS. 50A-B, where the extensionloop 890 can slide freely out of the connector 807. Having a permanentlyattached extension loop 890 may prevent loss of the filament in theoperating room.

The filament can be formed into the extension loop using any of a numberof different techniques. FIGS. 58A-G show various ways to form extensionloops. FIG. 58A shows a filament bonded to a sleeve bushing. FIG. 58Bdepicts a knotted filament. As seen in FIG. 58C, the filament iscontinuous (this could be done by butting the two ends of the filamenttogether and melting or bonding them). FIG. 58D shows an internalconnector inserted into the ends of the filament. FIG. 58E depicts anends connector which receives the two free ends of the filament. FIG.58F shows a figure-8 shaped extension loop formed by twisting the ovalloop, and FIG. 58G depicts a figure-8 shaped extension loop formed byusing a sleeve to bring together the central portion of the oval loop.

Of these approaches, the use of an end connector may be of the mostinterest because it allows a length of tubing to be quickly formed intoan extension loop.

With reference now to FIGS. 59-60B, an end connector 970 is depictedthat is suitable for attachment to the two ends 968 of a tubularfilament to form an extension loop 990. This connector 970, rather thanthe loop material, can be held in the cavity 954 in the tip 904 of theintroducer needle 903. The end connector 970 is generally U-shaped. Eachleg of the U has a barbed extension 972 protruding therefrom thatprovides a frictional fit with a length of tubing fit thereon. Movingalong either of the arms of the U and away from the curve of the U, thebarbed extension has a cylindrical region 976 a of first width WI, atapered first barbed section 974 a decreasing in width, followed by acylindrical region 976 b of second width W2, and a second barbed section974 b that also decreases in width until it reaches a blunt tip 978. Asshown in FIG. 59, the wide end of each barbed section 974 a, 974 b iswider than the width of the cylindrical region 976 to which it isadjacent. This way, the end of a length of elastic tubing can beadvanced over the barbed sections 974 a, 974 b and cylindrical regions976 and will be deformed somewhat by the barbed regions 974 a, 974 b,which will then prevent the tubing from being pulled backward and awayfrom the connector 907.

The U-shaped connector 970 can be made from any suitable biocompatiblematerial such as plastic or metal, and preferably has a smooth andnon-irritating surface finish. If desired, a low-friction coating couldbe applied.

Also, the connection between the U-shaped connector 970 and the tubingcould be made by bonding or welding.

FIGS. 60A and 60B illustrate how an extension loop 990 formed using theU-shaped connector 970 of FIG. 59 can be captured at the tip 904 of anintroducer needle 903. As shown, the introducer needle tip 904 has a“T”-shaped cavity 934 formed therein. The recess has legs which are ofthe right size to receive the curved portion of the U-shaped connector970. The U-shaped connector 970 passes through the base of the“T”-shaped cavity 934 and then sits one of the two ends of the crossbarof the “T”, depending upon whether the introducer needle 903 is beingadvanced into or withdrawn from the patient's body to position theimplant member 901. As shown in FIG. 60 the introducer needle 903 willbe withdrawn from the patient's body to draw the implant member 901 intoplace.

Alternatively, the extension loop 990 shown in FIG. 60A could be formedby joining the two ends of the filament together, say, by placing oneloop end inside the other.

It also should be understood that the extension loop 990 used in FIG.60A could be made from flat tape, solid cord, or any other suitablematerial.

An alternate needle tip configuration for capturing the U-shapedconnector is depicted in FIGS. 61A-B. Here, the tip 1004 of the needle1003 has an “H” shaped opening 1027, the grooves forming the “H” beingsized to securely receive the U-shaped connector 1070. As shown in FIG.61B, the legs of the curved portion of the U-shaped connector 1070 fitinto the ends of the long legs of the H. The curved portion of theU-shaped connector 1070 runs from one long leg of the “H” around thesolid piece separating that leg from the other long leg, and into theother leg (it will be appreciated that this embodiment may work bestwith a U-shaped connector 1070 made of compliant material). Thisarrangement securely holds the U-shaped connector 1070 in place so thatthe introducer needle 1003 can be retracted, drawing the extension loop1090 and attached urethral support 1081 into the patient's body.

It will be appreciated that if the implant member 1001 is to bepositioned by advancing the introducer needle 1003, then the curvedportion of the U-shaped connector 1070 can be attached in the samemanner as discussed above to the other ends of the long legs of the “H”shaped opening in the needle tip 1004.

FIGS. 62A-B depict another embodiment of a U-shaped end connector 1170that can be used to form an extension loop 1190. This U-shaped connector1170 is generally similar to that shown in FIG. 59, but in place of theopen portion of the U the connector 1170 carries a solid base portion1192 from which extends a cylindrical projection 1194 having a diameterD. The top 1196 of the projection 1194 is enlarged and has a diameter D′that is somewhat larger than diameter D. Thus, the top portion 1196serves as a flange.

The U-shaped connector 1170 shown in FIG. 62A is used with and isreceived by a needle 1103 having a slot 1127 formed therein as shown inFIG. 62B. The slot 1127 is generally rectangular, with rounded endportions and a curved opening 1198 at its center. The opening 1198 isslightly larger than the diameter D′ of the top 1196 of the projection1194 on the U-shaped connector 1170. The rest of the slot 1127 has awidth that is slightly wider than the diameter D of the cylindricalprojection 1194 on the U-shaped connector 1170, but which is stillnarrower than the diameter D′ of the top 1196 of the projection 1194.This way, the U-shaped connector 1170 can be joined to the introducerneedle 1103 by fitting the projection 1194 into the curved opening 1198of the slot 1127 and then moving the U-shaped connector 1170 along thelength of the slot 1127 so that the cylindrical portion 1194 rides inthe slot 1127 and is held in place because the flat, spatulated sectionof the instrument 1113 is held between the top 1196 of the projection1194 and the base 1192 of the U-shaped connector 1170.

Because the projection 1194 is cylindrical, it is possible for theconnector 1170 to rotate in a plane which is perpendicular to the planethat the needle tip lies in.

FIGS. 63A and 63B depict a modification of the embodiment shown in FIGS.62A-B. In this structure, the U-shaped connector 1270 has anupwardly-extending rectangular projection 1294 or tab having an enlargedhead region 1296. The needle tip 1204 has a generally-rectangular slot1227 of a given width with an enlarged central opening 1298 that isdimensioned to receive the enlarged head region 1296 of the U-shapedconnector 1270. As with the previous embodiment, when the U-shapedconnector 1270 is moved along the slot 1227, the flat, spatulatedsection 1213 of the introducer needle 1203 is held between the solidbase 1292 of the U-shaped connector 1270 and the enlarged head region1296. Again, this secures the U-shaped connector 1270 to the needle.

Furthermore, the rectangular shape of the projection 1294 preventsrotation of the connector 1270 relative to the needle in a plane lyingparallel to the plane in which the needle tip lies (by suitablyadjusting the relative side of the tab and slot, some degree of rotationcould be allowed).

Next, techniques for using this invention will be described.

The present invention can be used for implantation via either anabdominal or vaginal approach. Such versatility is a strong benefit ofthe invention, as it provides surgeons with the option of usingwhichever approach they feel most comfortable with.

In the abdominal approach, appropriate anesthesia is chosen according tothe physician's preference. Then, at least one small skin nick is madein the abdominal wall at the level of the pubic symphysis, just lateralto the midline if two nicks are created. A small incision is made in theanterior vaginal wall just below the urethral meatus. If not alreadydone, the handle is attached to the first introducer needle, and theassembly is advanced into the retropubic space via one of the abdominalincisions. The needle is further advanced downward until the needle tipis exposed at the vaginal incision. Next, a cystoscopy is performed toconfirm bladder integrity. One end of the tissue implant is connected tothe needle tip, preferably using the permanent snap-on tissue connector,and the introducer is withdrawn from the abdominal incision with thetissue attached. The handle is then disconnected from the first needleand attached to the second needle.

The steps starting with attachment of the handle to the needle throughwithdrawal of the introducer from the abdominal incision with the tissueimplant attached are repeated on the contralateral side using the secondneedle and connector. The implant member now forms a U-shaped loopbeneath the urethra, and the ends of the U are available at theabdominal incisions.

At this point the implant member is positioned loosely under the urethraby either gently tightening the strip by pulling on the abdominal endsof the implant or, if necessary, by loosening the strip by pulling onthe implant with a clamp at the vaginal incision. The textured design ofthe implant allows it to anchor itself in the patient's own tissue,eliminating the need for suturing.

Once the appropriate implant position is achieved, the abdominal ends ofthe implant are cut just below the level of the skin and all incisionsare closed. The introducer needles and connectors are then discarded(although the needles could be sterilized and reused, that is notpresently preferred).

It should be understood that instead of using a single handle, twohandles could be provided, one for each of the introducer needles.

In the vaginal approach, appropriate anesthesia is chosen according tothe physician's preference and at least one small skin nick is made inthe abdominal wall at the level of the pubic symphysis, just lateral tothe midline if two nicks are created. A small incision is made in theanterior vaginal wall just below the urethral meatus. The handle isattached to the first introducer needle, and the introducer needle isinserted, via the vaginal incision, and advanced upward until the tip isexposed through the first abdominal incision. A cystoscopy is performedto confirm bladder integrity and the handle is disconnected from theintroducer needle. One end of the tissue implant is connected at thevaginal end of the introducer via the permanent snap-on tissueconnector, as shown and described in FIGS. 7A-10. The introducer is thenused to draw the implant up to the first abdominal incision. The stepsof attaching the handle to the introducer needle through using theintroducer to draw the tissue implant up to the abdominal incision arethen repeated using the second needle and connector on the patient'scontralateral side. The implant member now forms a U-shaped loop underthe urethra with the ends of the U available at the abdominal incisions.

The implant member is positioned loosely under the urethra by eithertightening the strip with the abdominal ends of the implant or looseningthe strip by pulling on the implant with a clamp at the vaginalincision. The textured design of the implant allows it to anchor itselfin the patient's own tissue, eliminating the need for suturing.

Once the appropriate position is achieved, the abdominal ends of theimplant are cut just below the level of the skin and all incisions areclosed. The introducer needles and connectors are then discarded (again,while the needles could be sterilized for reuse, that is not presentlypreferred).

Again, it should be understood that instead of using a single handle,two handles could be provided, one for each of the introducer needles.

Together, the components used in this invention provide a minimallyinvasive, simple technique that is easily learned and which requireslittle operative time. The implant member will offer the lowcomplication rate and good tissue ingrowth of a natural material, whilethe texturing provides the self-anchoring properties of a syntheticmesh, thereby eliminating the need for sutures or other anchoring means.

Thus, while there have been shown and described and pointed out novelfeatures of the present invention as applied to preferred embodimentsthereof, it will be understood that various omissions and substitutionsand changes in the form and details of the disclosed invention may bemade by those skilled in the art without departing from the spirit ofthe invention. It is the intention, therefore, to be limited only asindicated by the scope of the claims appended hereto.

It is also to be understood that the following claims are intended tocover all of the generic and specific features of the invention hereindescribed and all statements of the scope of the invention which, as amatter of language, might be said to fall therebetween.

What is claimed is:
 1. A method of treating urinary incontinence byimplanting a transvaginal mid-urethral sling into a person, the methodcomprising: forming a vaginal incision in a vaginal wall of a patientfor access to a urethra; providing an implant having a middle urethrasupport, a first extension attached to a first end portion of the middleurethra support, and a second extension attached to a second end portionof the middle urethra support, where each of the first extension and thesecond extension is a tube of material; providing an introducer needlehaving a body that terminates in a tip, where the tip is adapted todissect tissue; engaging the introducer needle with the first extensionof the implant prior to passage of the implant into the patient;advancing the introducer needle and the first extension of the implantfrom the vaginal incision, along a first path posterior to a pubic bone,and through an abdomen of the patient; disengaging the introducer needlefrom the first extension of the implant and withdrawing the introducerneedle backward along the first path from posterior to the pubic boneout of the vaginal incision; pulling on the first extension of theimplant and positioning the middle urethra support beneath the urethra;passing the introducer needle and the second extension of the implantfrom the vaginal incision, along a second path posterior to the pubicbone, and through the abdomen of the patient; and removing the firstextension and the second extension from the middle urethra support. 2.The method of claim 1, further comprising: compressing the firstextension onto the introducer needle and securing the first extension tothe introducer needle.
 3. The method of claim 1, wherein each of thefirst extension and the second extension is molded of a polymericmaterial, and engaging the introducer needle with the first extension ofthe implant comprises engaging the introducer needle with the moldedpolymeric material.
 4. The method of claim 1, further comprising:forming a first incision in the abdomen of the patient and advancing theintroducer needle and the first extension of the implant from thevaginal incision, along the first path posterior to the pubic bone, andthrough the first incision in the abdomen of the patient.
 5. The methodof claim 1, further comprising: forming a second incision in the abdomenof the patient and passing the introducer needle and the secondextension of the implant from the vaginal incision, along the secondpath posterior to the pubic bone, and through the second incision in theabdomen of the patient.
 6. The method of claim 1, further comprising:advancing the introducer needle and the first extension of the implantfrom the vaginal incision, along the first path posterior to the pubicbone, pushing the tip of the introducer needle through the abdomen ofthe patient, and leaving the first extension protruding outward from theabdomen of the patient.
 7. The method of claim 1, further comprising:using the first extension and the second extension to adjust a positionof the implant in the patient.
 8. The method of claim 1, furthercomprising: advancing the introducer needle and the first extension ofthe implant from the vaginal incision, through a retropubic space andthrough the abdomen of the patient; disengaging the introducer needlefrom the first extension of the implant and withdrawing the introducerneedle from the retropubic space and out of the vaginal incision.
 9. Amethod of treating urinary incontinence by implanting a transvaginalmid-urethral sling into a person, the method comprising: forming avaginal incision in a vaginal wall of a patient for access to a urethra;forming a first abdominal incision and a second abdominal incision inthe patient; providing an implant having a middle urethra support, afirst extension attached to a first end portion of the middle urethrasupport, and a second extension attached to a second end portion of themiddle urethra support, where each of the first extension and the secondextension is a tube of material; providing an introducer needle having abody with a first end that is permanently secured to a handle and asecond end that terminates in a tip; engaging the introducer needle withthe first extension of the implant; advancing the introducer needle andthe first extension of the implant from the vaginal incision, along afirst path posterior to a pubic bone, and through the first abdominalincision of the patient; disengaging the introducer needle from thefirst extension of the implant and withdrawing the introducer needlebackward along the first path from posterior to the pubic bone out ofthe vaginal incision; engaging the introducer needle with the secondextension of the implant; advancing the introducer needle and the secondextension of the implant from the vaginal incision, along a second pathposterior to the pubic bone, and through the second abdominal incisionof the patient; disengaging the introducer needle from the secondextension of the implant and withdrawing the introducer needle backwardalong the second path from posterior to the pubic bone out of thevaginal incision; pulling on the first extension and the secondextension of the implant and positioning the middle urethra supportbeneath the urethra; and removing the first extension and the secondextension from the middle urethra support.
 10. The method of claim 9,wherein each of the first extension and the second extension is moldedof a polymeric material, and engaging the introducer needle with thefirst extension of the implant comprises engaging the introducer needlewith the molded polymeric material.
 11. A method of treating urinaryincontinence by implanting a transvaginal mid-urethral sling into aperson, the method comprising: forming a vaginal incision in a vaginalwall of a patient for access to a urethra; forming a first abdominalincision and a second abdominal incision in the patient; providing animplant having a middle urethra support, a first extension attached to afirst end portion of the middle urethra support, and a second extensionattached to a second end portion of the middle urethra support, whereeach of the first extension and the second extension is a tube ofmaterial; providing an introducer needle having a body with a first endthat is secured to a handle and a second end that terminates in a tip;engaging the introducer needle with the first extension of the implant;advancing the introducer needle and the first extension of the implantfrom the vaginal incision, along a first path through a retropubic spaceposterior to a pubic bone, and through the first abdominal incision ofthe patient; disengaging the introducer needle from the first extensionof the implant, withdrawing the introducer needle backward along thefirst path out of the retropubic space and out of the vaginal incision,and leaving the first extension protruding outward from an abdomen ofthe patient; engaging the introducer needle with the second extension ofthe implant; advancing the introducer needle and the second extension ofthe implant from the vaginal incision, along a second path through theretropubic space posterior to the pubic bone, and through the secondabdominal incision of the patient; disengaging the introducer needlefrom the second extension of the implant, withdrawing the introducerneedle backward along the second path out of the retropubic space andout of the vaginal incision, and leaving the second extension protrudingoutward from the abdomen of the patient; pulling on the first extensionand the second extension of the implant and positioning the middleurethra support beneath the urethra; and removing the first extensionand the second extension from the middle urethra support.